AzTrials
AzTrials

Urinary Bladder OveractivePhase 3SYNERGYNCT01972841

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

A Phase 3 study testing Solifenacin succinate and Mirabegron in people with Urinary Bladder Overactive and Urinary Bladder Diseases\Urologic Diseases, run by Astellas Pharma Europe B.V. at 435 sites in 42 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Solifenacin succinate and Mirabegron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,527 participants
Where
435 sitesin 42 countries
Study dates
5 Nov 2013to 22 Oct 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
  • Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Who cannot join

  • Subject had significant PVR volume (> 150 mL);
  • Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
  • Subject had an indwelling catheter or practices intermittent self catheterization.
  • Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
  • Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
  • Subject had moderate to severe hepatic impairment
Show all 11Show fewer
  • Subject had severe renal impairment
  • Subject had a clinically significant abnormal ECG
  • Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
  • Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
  • Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

Trial locations and contacts

435 sites in 42 countries.

435 sites in 42 countries

United States121 sites

  • Site US10077 Northeast Urogynecology

    Albany, New York, 12205

  • Site US10011 Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Site US10015 Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Site US10037 Atlanta Medical Research Institute

    Alpharetta, Georgia, 30005

  • Site US10122 Orange County Research Institute

    Anaheim, California, 92801

  • Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc

    Austin, Texas, 78745

  • Site US10008 Urologic Consultants of Southeastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

  • Site US10110 Montana Health Research Institute, Inc.

    Billings, Montana, 59102

  • Site US10282 Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Site US10060 Meridien Research

    Bradenton, Florida, 34208

  • Site US10089 Maimonides Medical Center

    Brooklyn, New York, 11220

  • Site US10013 Seattle Urology Research Center

    Burien, Washington, 98166

  • Site US10066 Texas Urology PA

    Carrollton, Texas, 75010

  • Site US10098 Skyline Research

    Cerritos, California, 90703

  • Site US10104 Clinical Research Advantage, Inc.

    Chandler, Arizona, 85224

  • Site US10166 Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Site US10050 Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Site US10076 Carolina Clinical Trials

    Concord, North Carolina, 28025

  • Site US10065 Advanced Research Associates

    Corpus Christi, Texas, 78414

  • Site US10128 Clinical Research Center of CT

    Danbury, Connecticut, 06810

  • Site US10034 Urology Center of Colorado

    Denver, Colorado, 80211

  • Site US10002 Urology Center Research Institute

    Englewood, New Jersey, 07631

  • Site US10026 AccuMed Research Associates

    Garden City, New York, 11530

  • Site US10558 Chesapeake Urology Research Associates

    Glen Burnie, Maryland, 21061

  • Site US10539 Citrus Valley Medical Research

    Glendora, California, 91741

  • Site US10152 Female Pelvic Medicine & Urogynecology Institute

    Grand Rapids, Michigan, 49503

  • Site US10094 University Medical Group

    Greer, South Carolina, 29650

  • Site US10082 American Clinical Trials

    Hawaiian Gardens, California, 90716

  • Site US10097 A.G.A. Clinical Trials DBA Neostart Group

    Hialeah, Florida, 33012

  • Site US10148 Best Quality Research, Inc.

    Hialeah, Florida, 33016

  • Site US10153 Palmetto Professional Research

    Hialeah, Florida, 33016

  • Site US10159 Urological Research Network

    Hialeah, Florida, 33016

  • Site US10534 South Florida Medical Research

    Hialeah, Florida, 33016

  • Site US10535 South Florida Medical Research

    Homestead, Florida, 33030

  • Site US10085 Centex Studies, Inc.

    Houston, Texas, 77062

  • Site US10108 Clinical Trial Network

    Houston, Texas, 77074

  • Site US10219 Methodist Urology Associates

    Houston, Texas, 77094

  • Site US10093 Pioneer Research Solutions, Inc.

    Houston, Texas, 77098

  • Site US10090 Protenium Clinical Research, LLC

    Hurst, Texas, 76054

  • Site US10165 East Coast Institute for Research

    Jacksonville, Florida, 32216

  • Site US10091 Health Awareness

    Jupiter, Florida, 33458

  • Site US10006 Holston Medical Group

    Kingsport, Tennessee, 37660

  • Site US10040 Premier Medical Group Of The Hudson Valley

    Kingston, New York, 12401

  • Site US10088 Centex Studies, Inc.

    Lake Charles, Louisiana, 70601

  • Site US10070 Physicians' Research Options/Red Rocks OB/GYN

    Lakewood, Colorado, 80228

  • Site US10045 Lancaster Urology

    Lancaster, Pennsylvania, 17604

  • Site US10140 IVCTLV

    Las Vegas, Nevada, 89106

  • Site US10051 AdvancedMed Research

    Lawrenceville, New Jersey, 08648

  • Site US10047 Lawrence OBGYN Associates

    Lawrenceville, New Jersey, 86480

  • Site US10553 Women's Clinic of Lincoln

    Lincoln, Nebraska, 68510

  • Site US10132 Axis Clinical Trials

    Los Angeles, California, 90017

  • Site US10133 Axis Clinical Trials

    Los Angeles, California, 90036

  • Site US10033 Ohio Clinical Research

    Lyndhurst, Ohio, 44124

  • Site US10541 Sunstone Medical Research

    Medford, Oregon, 97504

  • Site US10074 Medpharmics, LLC

    Metairie, Louisiana, 70006

  • Site US10154 Montana Medical Research Inc

    Missoula, Montana, 59801

  • Site US10049 Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Site US10112 TFI, LLC

    Mobile, Alabama, 36608

  • Site US10162 Phoenix OB-GYN Associates, LLC

    Moorestown, New Jersey, 08057

  • Site US10004 Integrity Medical Research, LLC

    Mountlake Terrace, Washington, 98043

  • Site US10046 Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Site US10079 PMG Research of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Site US10117 Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Site US10018 Grove Hill Clinical Research

    New Britain, Connecticut, 06052

  • Site US10170 Yale - New Haven Hospital West Haven VAMC

    New Haven, Connecticut, 06510

  • Site US10150 Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Site US10073 Manhattan Medical Research Practice, PLLC

    New York, New York, 10016

  • Site US10249 New York Clinical Trials

    New York, New York, 10018

  • Site US10168 Weill Cornell Medical College

    New York, New York, 10065

  • Site US10126 Premier Medical Group

    Newburgh, New York, 12550

  • Site US10158 Renstar Medical Research

    Ocala, Florida, 34471

  • Site US10109 Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Site US10124 Winter Park Urology Associates

    Orlando, Florida, 32803

  • Site US10134 Compass Research, LLC

    Orlando, Florida, 32806

  • Site US10560 Chesapeake Urology Research Associates

    Owings Mills, Maryland, 21117

  • Site US10536 Stanford School of Medicine

    Palo Alto, California, 93404

  • Site US10149 Bayview Research Group

    Paramount, California, 90723

  • Site US10009 South Broward Research

    Pembroke Pines, Florida, 33027

  • Site US10540 Demaur Clinical Research, INC

    Pembroke Pines, Florida, 33028

  • Site US10017 Philadelphia Clinical Research, LLC

    Philadelphia, Pennsylvania, 19114

  • Site US10021 Beach Clinical Studies

    Phoenix, Arizona, 85051

  • Site US10167 University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Site US10250 Preferred Primary Care Physicians Inc.

    Pittsburgh, Pennsylvania, 15236

  • Site US10248 Preferred Primary Care Physicians, Inc

    Pittsburgh, Pennsylvania, 15243

  • Site US10554 Private Practice

    Plantation, Florida, 33317

  • Site US10028 Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Site US10129 PMG Research of Raleigh

    Raleigh, North Carolina, 27609

  • Site US10549 Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Site US10032 National Clinical Research Inc.

    Richmond, Virginia, 23294

  • Site US10127 Perimeter North Medical Research, Inc.

    Roswell, Georgia, 30076

  • Site US10559 UC Davis Medical Center

    Sacramento, California, 95817

  • Site US10105 Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Site US10111 Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Site US10003 San Diego Clinical Trials

    San Diego, California, 92120

  • Site US10545 San Diego Institute for Sexual Medicine

    San Diego, California, 92120

  • Site US10092 Physicians' Research Options/Salt Lake Women's Center

    Sandy City, Utah, 84070

  • Site US10120 WR-Mount Vernon Clinical Research

    Sandy Springs, Georgia, 30328

  • Site US10095 Florida Urology Specialists

    Sarasota, Florida, 34237

  • Site US10542 Adult & Pediatric Urology Group

    Sartell, Minnesota, 56377

  • Site US10155 Seattle Women's Health, Research, Gynecology

    Seattle, Washington, 98105

  • Site US10024 GTC Research

    Shawnee Mission, Kansas, 66218

  • Site US10025 Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Site US10023 Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina, 29681

  • Site US10101 Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Site US10010 Southeastern Research Group, Inc

    Tallahassee, Florida, 32308

  • Site US10106 West Coast Clinical Research

    Tarzana, California, 91356

  • Site US10063 Preferred Primary Care Physician Research

    Uniontown, Pennsylvania, 15401

  • Site US10595 Bayview Research Group

    Valley Village, California, 91607

  • Site US10064 The Group for Women

    Virginia Beach, Virginia, 23456

  • Site US10083 Urology of Virginia, PLLC.

    Virginia Beach, Virginia, 23462

  • Site US10067 Family Practice Center of Wadsworth

    Wadsworth, Ohio, 44281

  • Site US10135 Walla Walla Clinic

    Walla Walla, Washington, 99362

  • Site US10123 Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Site US10114 Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 02472

  • Site US10014 Private Practice

    Wellington, Florida, 33449

  • Site US10551 The Christ Hospital

    West Chester, Ohio, 45069

  • Site US10012 Advanced Clinical Concepts

    West Reading, Pennsylvania, 19611

  • Site US10053 Western Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033

  • Site US10078 Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Site US10593 Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

  • Site US10062 Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada26 sites

  • Site CA15001 The Male/Female Health & Research Centre

    Barrie, Ontario, L4M 7G1

  • Site CA15006 Bramalea Medical Centre

    Brampton, Ontario, L6T 4S5

  • Site CA15003 Brantford Urology Research

    Brantford, Ontario, N3R 4N3

  • Site CA15042 G. Kenneth Jansz Medicine Professional Corporation

    Burlington, Ontario, L7N 3V2

  • Site CA15026 Rhodin Recherche Clinique

    Drummondville, Quebec, J2B 7T1

  • Site CA15029 Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Site CA15035 Glenrose Rehabilitation Hospital

    Edmonton, Alberta, T6G 2P4

  • Site CA15015 Recherches Cliniques Theradev, Inc.

    Granby, Quebec

  • Site CA15021 Urology South Shore Research

    Greenfield Park, Quebec, J4V 2H3

  • Site CA15044 McMaster Institute of Urology

    Hamilton, Ontario, L8N 4A6

  • Site CA15031 Centre for Applied Urology Research (CAUR)

    Kingston, Ontario, K7L 3J7

  • Site CA15007 Eunoia2 Incorporated

    Kitchener, Ontario, N2N 2B9

  • Site CA15030 UroLaval

    Laval, Quebec, H7G 2E6

  • Site CA15034 Oxford/Richmond Medical

    London, Ontario, N6A 5R9

  • Site CA15040 RechercheGCP Research

    Montreal, Quebec, H2R1V6

  • Site CA15020 Diex Research Montreal

    Montreal, Quebec, H4N 3C5

  • Site CA15032 Stanley Flax Medical Prof Corp

    North York, Ontario, M2J 1V1

  • Site CA15010 Ultra Med Research, Inc.

    Point-Claire, Quebec, H9R 4S3

  • Site CA15025 Clinique RSF Inc.

    Québec, Quebec, G1S 2L6

  • Site CA15008 Private Practice

    Saint John, New Brunswick, E2L 3J8

  • Site CA15039 Pro-recherche

    Saint Romuald, Quebec, G6W 5M6

  • Site CA15027 Diex Research Sherbrooke Inc

    Sherbrooke, Quebec, J1H 1Z1

  • Site CA15013 Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Site CA15004 Primehealth Clinical Research

    Toronto, Ontario, M4S 1Y2

  • Site CA15002 Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Site CA15033 Prohealth

    Vancouver, British Columbia, V5Z 4E1

Other trials in Canada

South Korea26 sites

  • Site KR82014 Soon Chun Hyang University Hospital

    Bucheon-si, 420-767

  • Site KR82006 Dong-A University Medical Center

    Busan, 602-715

  • Site KR82016 Pusan National University Hospital

    Busan, 602-739

  • Site KR82024 Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Site KR82032 Kyungpook National University Hospital

    Daegu, 700-421

  • Site KR82005 Yeungnam University Hospital

    Daegu, 705-717

  • Site KR82029 Daegu Catholic Univ. Medical Center

    Daegu, 705-718

  • Site KR82019 Chungnam National University Hospital

    Daejeon, 301-721

  • Site KR82011 Eulji University Hospital

    Daejeon, 302-799

  • Site KR82031 Chonnam National University Hospital

    Gwangju, 501757

  • Site KR82009 Wonkwang University Hospital

    Iksan -Si, 570-711

  • Site KR82023 Gachon University Gil Hospital

    Incheon, 405760

  • Site KR82010 Chonbuk National University Hospital

    Jeonju, 561-712

  • Site KR82025 Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Site KR82021 Cheil General Hospital & Women's Healthcare Center

    Seoul, 100-380

  • Site KR82020 Seoul National University Hospital

    Seoul, 110-744

  • Site KR82030 Severance Hospital

    Seoul, 120-752

  • Site KR82013 Hallym University Kangdong Sacred Heart Hospital

    Seoul, 134-701

  • Site KR82017 Kyung Hee University Medical Center

    Seoul, 134-872

  • Site KR82002 Samsung Medical Center

    Seoul, 135-710

  • Site KR82008 Gangnam Severance Hospital

    Seoul, 135-720

  • Site KR82015 Korea University Medical Center

    Seoul, 136-075

  • Site KR82001 Seoul Saint Mary's Hospital

    Seoul, 137-040

  • Site KR82003 Asan Medical Center

    Seoul, 138-736

  • Site KR82012 Konkuk University Medical Center

    Seoul, 143-729

  • Site KR82004 Ajou University Hospital

    Suwon, 443-721

Other trials in South Korea

China22 sites

  • Site CN86025 Beijing Friendship Hospital

    Beijing, 100050

  • Site CN86009 Peking University 3rd Hospital

    Beijing, 100191

  • Site CN86013 Beijing Hospital

    Beijing, 100730

  • Site CN86014 The First Hospital Bethune of Jilin University

    Changchun, 130021

  • Site CN86002 Changsha Central Hospital

    Changsha, 410008

  • Site CN86028 General Hospital of Chengdu Military Region of PLA

    Chengdu

  • Site CN86029 Southwest Hospital (Chongqing)

    Chongqing, 400038

  • Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.

    Fuzhou, Fujian, 350001

  • Site CN86016 Guangzhou First People's Hospital

    Guangzhou, 510180

  • Site CN86027 Second Hospital of Lanzhou University

    Lanzhou, 730030

  • Site CN86030 Lanzhou University First Hospital

    Lanzhou

  • Site CN86020 The First Affiliated Hospital of NanChang Univers

    Nanchang, 330006

  • Site CN86023 Nanjing First Hospital

    Nanjing, 210006

  • Site CN86021 HuaDong Hosipital Affiliated to Fudan University

    Shanghai, 200040

  • Site CN86003 Shanghai Renji Hospital

    Shanghai, 200127

  • Site CN86012 The Fifth People's Hospital of Shanghai

    Shanghai, 200240

  • Site CN86011 The Second Affiliated Hospital of Soochow Universi

    Suzhou, 215004

  • Site CN86010 1st Affiliated Hosptital of Suchow University

    Suzhou, 215006

  • Site CN86026 The First Affiliated Hospital of Wenzhou Medical C

    Wenzhou, 325000

  • Site CN86022 Tongji Hospital, Tongji Medical College of Hust

    Wuhan, 430030

  • Site CN86015 Zhongnan Hospital of Wuhan University

    Wuhan, 430071

  • Site CN86018 Wuxi People's Hospital

    Wuxi, 214023

Other trials in China

Australia15 sites

  • Site AU61026 Ballarat Urology

    Ballarat, 3350

  • Site AU61022 Brisbane South Clinical Research Centre

    Brisbane, 4152

  • Site AU61005 Hunter Clinical Research

    Broadmeadow, 2292

  • Site AU61015 Repatriation General Hospital

    Daw Park, 5041

  • Site AU61025 Western Health

    Footscray, 3011

  • Site AU61012 Cabrini Hospital

    Malvern, 3144

  • Site AU61010 Nambour General Hospital

    Nambour, 4560

  • Site AU61002 The Royal Womens Hospital

    Parkville, 3052

  • Site AU61004 Keogh Institute for Medical Research

    Perth, 6009

  • Site AU61007 Prince of Wales Hospital

    Randwick, 2031

  • Site AU61008 Epworth Healthcare

    Richmond, 3121

  • Site AU61019 AusTrialsSherwood

    Sherwood, 4075

  • Site AU61017 Healthpac Medical Centre

    Sydney, 2000

  • Site AU61021 Royal Hospital for Women

    Sydney, 2031

  • Site AU61011 Illawarra Health and Medical Research Institute

    Wollongong, 2522

Other trials in Australia

Germany13 sites

  • Site DE49008 Private Practice

    Bad Ems, 56130

  • Site DE49031 Urologisches Zentrum Refrath

    Bergisch Gladbach, 51427

  • Site DE49033 Universitsy Clinic Bonn

    Bonn, 53217

  • Site DE49002 Private Practice

    Duisburg, 47051

  • Site DE49032 Urologicum Duisburg

    Duisburg, 47179

  • Site DE49003 Private Practice

    Eisleben Lutherstadt, 6295

  • Site DE49010 Private Practice

    Ganderkesee, 27777

  • Site DE49011 Private Practice

    Halle, 06132

  • Site DE49013 Private Practice

    Leipzig, 04105

  • Site DE49034 LMU Muenchen

    Munich, 81377

  • Site DE49001 Private Practice

    Neustadt in Sachsen, 1844

  • Site DE49026 Zentrum fuer Onkologie und Urologie Rostock

    Rostock, 18107

  • Site DE49014 Private Practice

    Sangerhausen, 6526

Other trials in Germany

Czechia12 sites

  • Site CZ42015 Centrum ambulantni gynekologie a primarni pece

    Brno, 602 00

  • Site CZ42003 SANUS

    Hradec Králové, 500 02

  • Site CZ42001 Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Site CZ42002 Hospital Jihlava

    Jihlava, 586 33

  • Site CZ42011 Hospital Novy Jicin

    Nový Jičín, 741 01

  • Site CZ42010 G-centrum Olomouc S.R.O.

    Olomouc, 772 00

  • Site CZ42014 Private Practice

    Ostrava, 700 30

  • Site CZ42005 Research Site s.r.o.

    Pilsen, 301 00

  • Site CZ42007 Uro-Santé/Nová Brumlovka

    Prague, 140 00

  • Site CZ42013 Urology Clinic

    Sternberk, 78501

  • Site CZ42009 Hospital Uherské Hradiště a.s.

    Uherské Hradiště, 686 08

  • Site CZ42006 Private Practice

    Ústí nad Labem, 40001

Other trials in Czechia

Poland12 sites

  • Site PL48018 Gastromed

    Bialystok, 15-351

  • Site PL48013 Urovita Ltd.

    Chorzów, 41-500

  • Site PL48014 Synexus Polska

    Gdynia, 81-384

  • Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne

    Lodz, 90-302

  • Site PL48010 Nzoz Novita

    Lublin, 20-632

  • Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.

    Mysłowice, 41-400

  • Site PL48016 Prywatny Gabinet Urologiczny

    Opole, 45-086

  • Site PL48005 HEUREKA Hanna Szalecka

    Piaseczno, 05-500

  • Site PL48012 Military Institute of Medicine

    Warsaw, 00-909

  • Site PL48003 CSKMSW

    Warsaw, 02-507

  • Site PL48001 Specjalistyczny Gabinet Lekarski

    Warsaw, 02-929

  • Site PL48019 Synexus Polska sp. z o. o.

    Wroclaw, 50-088

Other trials in Poland

Spain11 sites

  • Site ES34010 Hospital del Henares

    Coslada, 28822

  • Site ES34024 Hospital San Juan de Dios

    Esplugues de Llobregat-Barcelo, 08950

  • Site ES34001 Hospital Universitario de Getafe

    Getafe (Madrid), 28905

  • Site ES34006 Hospital San Rafael

    Madrid, 28016

  • Site ES34004 Hospital Infanta Leonor

    Madrid, 28031

  • Site ES34015 Hospital 12 de Octubre

    Madrid, 28044

  • Site ES34009 Hospital Universitario La Paz

    Madrid, 28046

  • Site ES34005 Hospital de Fuenlabrada

    Madrid, 28942

  • Site ES34003 Hospital Universitario Nuestra Señora de Valme

    Seville, 41001

  • Site ES34007 Hospital Virgen del Rocio

    Seville, 41013

  • Site ES34002 H. U. Politecnico La Fe

    Valencia, 46026

Other trials in Spain

France10 sites

  • Site FR33007 Centre Hospitalier Louis Pasteur

    Colmar, 68024

  • Site FR33010 CHU Hopital du Bocage

    Dijon, 21079

  • Site FR33008 CHU Nantes

    Nantes, 44035

  • Site FR33002 CHU Carémeau

    Nîmes, 30029

  • Site FR33013 Hopital Saint Louis

    Paris, 75475

  • Site FR33001 Hopital Tenon

    Paris, 75970

  • Site FR33024 Hopital Tenon

    Paris, 75970

  • Site FR33011 Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Site FR33012 Hopital Foch

    Suresnes, 92151

  • Site FR33005 Hopital Bretonneau

    Tours, 37044

Other trials in France

Ukraine10 sites

  • Site UA38002 City Hospital No 2

    Chernihiv, 14034

  • Site UA38015 Regional Municipal Institution, Urology Department

    Chernivtsi, 58000

  • Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov

    Dnipropetrovsk, 49005

  • Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology

    Kharkiv, 61037

  • Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric

    Kiev, 02232

  • Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3

    Kyiv, 02660

  • Site UA38010 Academy of Medical Sciences of Ukraine

    Kyiv, 04053

  • Site UA38014 Uzhgorod City Polyclinic

    Uzhhorod, 88000

  • Site UA38004 Vinnitsa Endocrinology Dispens

    Vinnytsia, 21010

  • Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic

    Zaporizhzhya, 69600

Other trials in Ukraine

Lithuania9 sites

  • Site LT37008 Kaunas 2nd Clinical Hospital

    Kaunas, 47144

  • Site LT37004 KHospital of Lithuanian University of Health Science

    Kaunas, 50009

  • Site LT37011 Saules Family Medicine Centre

    Kaunas

  • Site LT37012 Klaipeda University Hospital

    Klaipėda, LT-92288

  • Site LT37005 Public Institution Vilnius City University Hospital

    Vilnius, 10207

  • Site LT37010 Public Institution Vilnius City University Hospital

    Vilnius, 10207

  • Site LT37003 Family Medical Centre Seimos gydytojas

    Vilnius, LT-01118

  • Site LT37007 Vilnius University Hospital Santariskiu Klinikos

    Vilnius, LT-08661

  • Site LT37009 Clinics Privatus gydytojas

    Vilnius, LT-09108

Other trials in Lithuania

Sweden9 sites

  • Site SE46007 Ladulaas Clinical Studies

    Borås, 506 30

  • Site SE46025 Pharmasite

    Helsingborg, 252 20

  • Site SE46005 Center för Läkemedelsstudier

    Malmö, 211 52

  • Site SE46016 Citydiabetes - Stockholm

    Stockholm, 111 57

  • Site SE46008 Bragée Medect AB

    Stockholm, 115 22

  • Site SE46012 Karolinska University Hospital Huddinge

    Stockholm, 141 86

  • Site SE46003 Danderyds Hospital

    Stockholm, 182 88

  • Site SE46009 Encia AB, Uppsala Hälsomottagning

    Uppsala, 753 35

  • Site SE46017 S3 Clinical Research Centers

    Vällingby, 162 68

Other trials in Sweden

United Kingdom9 sites

  • Site GB44003 Leighton Hospital

    Crewe, CW1 4QJ

  • Site GB44009 Sheepcot Medical Centre

    Garston, Watfort, WD25 0EA

  • Site GB44021 Medway Hospital

    Gillingham, ME7 5WY

  • Site GB44005 North West London Hosp Menopause Clinic

    Harrow, HA1 3UJ

  • Site GB44024 St James's University Hospital

    Leeds, LS7 9TF

  • Site GB44025 Kings College Hospital

    London, SE5 9RS

  • Site GB44006 Derriford Hospital

    Plymouth, PL6 8DH

  • Site GB44022 The Royal Berkshire Hospital

    Reading, RG1 5AN

  • Site GB44001 Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Romania8 sites

  • Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov

    Brasov, 500152

  • Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan

    Bucharest, 42122

  • Site RO40001 Spiatlul Clinic Th. Burghele

    Bucharest, 50659

  • Site RO40005 Spiatlul Clinic Th. Burghele

    Bucharest, 50659

  • Site RO40014 E-URO Cabinet

    Cluj-Napoca, 400046

  • Site RO40007 Spital Clinic

    Iași, 700503

  • Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu

    Sibiu, 550245

  • Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara

    Timișoara, 300736

Other trials in Romania

Slovakia8 sites

  • Site SK42105 Ruzinovska poliklinika a.s.

    Bratislava, 82101

  • Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.

    Košice, 4001

  • Site SK42101 Andrologicka a Urologicka Ambulancia

    Košice, 4013

  • Site SK42103 UroExam s.r.o.

    Nitra, 949 01

  • Site SK42108 BrenCare, s. r. o.

    Poprad, 058 01

  • Site SK42104 Urology Outpatient Department

    Prešov, 8001

  • Site SK42106 Private Urological Care Center

    Trenčín, 911 01

  • Site SK42102 CeGys, s.r.o.

    Trenčín, 91101

Other trials in Slovakia

Thailand8 sites

  • Site TH66002 Chulalongkorn Hospital

    Bangkok, 10330

  • Site TH66008 Phramongkutklao Hospital

    Bangkok, 10400

  • Site TH66005 Siriraj Hospital

    Bangkok, 10700

  • Site TH66010 Maharaj Nakorm Chiangmai Hosp

    Chiang Mai, 50200

  • Site TH66006 Songklanagarind Hospital, Prince of Songkla University

    Hat Yai, 90110

  • Site TH66009 Srinagarind Hospital

    Khon Kaen, 40002

  • Site TH66007 Thammasat University Hospital

    Pathum Thani, 12120

  • Site TH66011 Ramathibodi Hospital

    Ratchathewi, 10400

Other trials in Thailand

Bulgaria7 sites

  • Site BG35904 University Hospital (UMHAT) - George Stranski

    Pleven, 5800

  • Site BG35908 MHAT Plovdiv AD

    Plovdiv, 4003

  • Site BG35902 MHAT Ruse

    Rousse, 7002

  • Site BG35905 MHAT Alexandrovska Hospital

    Sofia, 1431

  • Site BG35903 MHATEM Pirogov

    Sofia, 1606

  • Site BG35906 UMHAT Varna

    Varna, 9000

  • Site BG35910 MHAT

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Russia7 sites

  • Site RU70015 LLC Clinical Research Medical Complex

    Kazan', 420097

  • Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko

    Penza, 440026

  • Site RU70019 City Multidisciplinary Hospital No. 2

    Saint Petersburg, 194354

  • Site RU70002 Pavlov St. Petersburg State Medical University

    Saint Petersburg, 197089

  • Site RU70022 St. Petersburg State Public Health Institution

    Saint Petersburg, 198103

  • Site RU70014 OOO Hospital Orkli

    Saint Petersburg, 199178

  • Site RU70018 Bashkirsky State Medical University of Roszdrav

    Ufa, 450096

Other trials in Russia

Hungary6 sites

  • Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft

    Csongrád, 6640

  • Site HU36007 Mediroyal Prevention Center

    Kecskemét, 6000

  • Site HU36005 Uro-clin Ltd

    Pécs, 7621

  • Site HU36013 Sopron Erzsébet Hospital

    Sopron, H-9400

  • Site HU36001 Donatella 99BT

    Szentes, 6600

  • Site HU36012 Veszprém County Cholnoky Ferenc Hospital

    Veszprém, 8200

Other trials in Hungary

Malaysia6 sites

  • Site MY60006 Hospital Pulau Pinang

    George Town, 10990

  • Site MY60001 Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • Site MY60004 University Malaya Medical Centre

    Kuala Lumpur, 50603

  • Site MY60005 Universiti Kebangsaan Malaysia Medical Centre

    Kuala Lumpur, 56000

  • Site MY60003 Hospital Ummum Sarawak

    Kuching, 93586

  • Site MY60002 Sime Darby Medical Centre

    Petaling Jaya, 47500

Other trials in Malaysia

New Zealand6 sites

  • Site NZ64004 John A Tuckey Ltd Ascot Central

    Auckland, 1541

  • Site NZ64001 Canterbury Urology Research Trust

    Christchurch, 8014

  • Site NZ64005 Waikato Urology Research Limited

    Hamilton, 3204

  • Site NZ64002 Roundhay Medical Centre

    Nelson, 7010

  • Site NZ64003 Tauranga Urology Research Ltd

    Tauranga, 3140

  • Site NZ64006 Cardinal Point Specialist Centre

    Whangarei

Other trials in New Zealand

Peru6 sites

  • Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud

    La Victoria, Lima region, 13

  • Site PE51001 Instituto de Ginecologia y Reproduccion

    Lima, 33

  • Site PE51002 Clinica San Borja

    Lima, 41

  • Site PE51004 Clinica San Pablo

    Lima

  • Site PE51005 Hospital Nacional Hipolito Unanue

    Lima

  • Site PE51007 Clínica Anglo Americana

    San Isidro, Lima region, 27

Other trials in Peru

Philippines6 sites

  • Site PH63008 Dr. Pablo O. Torre Memorial Hospital

    Bacolod City, 6100

  • Site PH63005 Davao Doctor's Hospital

    Davao City, 8000

  • Site PH63010 Davao Doctor's Hospital

    Davao City, 8000

  • Site PH63003 University of Santo Tomas Hospital (USTH)

    Manila, 1008

  • Site PH63009 Chinese General Hospital and Medical Center

    Manila, 1008

  • Site PH63004 East Avenue Medical Center

    Quezon City, 1101

Other trials in Philippines

South Africa6 sites

  • Site ZA27005 Grootte Schuur Hospital

    Cape Town, 7925

  • Site ZA27001 Private Practice

    Centurion, 0157

  • Site ZA27006 Parklands Hospital

    Durban, 4001

  • Site ZA27013 Synexus Clinical Research SA (Pty) Ltd

    Meyerspark, 184

  • Site ZA27007 Paarl Medical Centre

    Paarl, 7646

  • Site ZA27002 Mayo Clinic

    Roodepoort, 1709

Other trials in South Africa

Argentina5 sites

  • Site AR54005 IUBA - Instituto Urologico de Buenos Aires

    Buenos Aires, 1419

  • Site AR54003 Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Site AR54006 Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Site AR54001 CDU - Centro de Urología

    Ciudad Autónoma Buenos Aires, C1120AAT

  • Site AR54004 Instituto de Investigaciones Clnicas Rosario

    Rosario Provincia de Santa Fe, 2000

Other trials in Argentina

Italy5 sites

  • Site IT39022 Azienda Ospedale Umberto I (Ancona)

    Ancona, 60126

  • Site IT39007 Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100

  • Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza

    Latina, 4100

  • Site IT39003 Ospedale San Raffaele

    Milan, 20132

  • Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia

    Milan, 20132

Other trials in Italy

Netherlands5 sites

  • Site NL31002 Academic Medical Center (AMC)

    Amsterdam, 1105 AZ

  • Site NL31006 Medisch Spectrum Twente

    Enschede, 7513ER

  • Site NL31005 Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

  • Site NL31010 Antonius Ziekenhuis Sneek

    Sneek, 8601 ZK

  • Site NL31001 University Medical Centre Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium4 sites

  • Site BE32004 Gent University Hospital

    Ghent, 9000

  • Site BE32011 Universitaire Ziekenhuizen Leuven

    Leuven, 3000

  • Site BE32014 Hart Ziekenhuis

    Roeselare, 8800

  • Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna

    Sint-Truiden, 3800

Other trials in Belgium

Mexico4 sites

  • Site MX52004 Consultorio de Especialidad en Urologia

    Durango, 34000

  • Site MX52001 Centro de Investigacin Basica y Clnica

    Guadalajara, 45040

  • Site MX52003 Clinstile, Sociedad Anonima de Capital Variable

    Mexico City, 6700

  • Site MX52002 Accelerium Clinical Research/ Hospital San Jorge

    Monterrey, 64000

Other trials in Mexico

Taiwan4 sites

  • Site TW88605 Taichung Veteran General Hospital

    Taichung, 40705

  • Site TW88611 Chung Shan Medical University Hospital

    Taichung, 407

  • Site TW88612 Chi Mei Medical Center, Yong Kang

    Tainan, 710

  • Site TW88614 Tri-Service General Hospital

    Taipei, 114

Other trials in Taiwan

Turkey (Türkiye)4 sites

  • Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital

    Ankara, 06100

  • Site TR90013 Uludag University Faculty of Medicine

    Bursa, 16059

  • Site TR90001 Pamukkale University Faculty of Medicine

    Denizli, 20070

  • Site TR90017 Bilim University Sisli Florence Nightingale Hospital

    Istanbul, 34381

Other trials in Turkey (Türkiye)

Estonia3 sites

  • Site EE37201 Parnu Hospital

    Pärnu, 80010

  • Site EE37205 West Tallinn Central Hospital

    Tallinn, 10617

  • Site EE37202 Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Finland3 sites

  • Site FI35801 Kouvolan Lääkäriasema

    Kouvola, 45200

  • Site FI35803 Oulu University Hospital

    Oulu, 90029

  • Site FI35802 Meilahti Hospital

    Vantaa, 01400

Other trials in Finland

Hong Kong3 sites

  • Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital

    Hong Kong

  • Site HK85201 Kwong Wah Hospital

    Kowloon

  • Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital

    Shatin, 30-32

Other trials in Hong Kong

Latvia3 sites

  • Site LV37102 Private Practice

    Liepāja, LV-3401

  • Site LV37103 Health Centre "Olaine"

    Olaine, LV-2114

  • Site LV37105 P.Stradins Clinical University Hospital

    Riga, 1002

Other trials in Latvia

Norway3 sites

  • Site NO47007 Medi3 Clinic AS, Ålesund

    Ålesund, 6003

  • Site NO47006 M3 Helse AS

    Hamar, 2317

  • Site NO47008 Norsk Helseklinikk (Heiaklinikken)

    Lierskogen, 3420

Other trials in Norway

Singapore3 sites

  • Site SG65001 National University Hospital

    Singapore, 119074

  • Site SG65002 Singapore General Hospital

    Singapore, 169608

  • Site SG65003 KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

Colombia2 sites

  • Site CO57003 Hospital Pablo Tobón Uribe

    Medellín, Antioquia

  • Site CO57004 Instituto de Coloproctologia ICO SAS

    Medellín

Other trials in Colombia

Denmark2 sites

  • Site DK45012 Aalborg Sygehus Nord

    Aalborg, 9000

  • Site DK45013 University Hospital of Aarhus, Skejby

    Aarhus, 8200

Other trials in Denmark

Slovenia2 sites

  • Site SI38604 General Hospital Murska Sobota

    Murska Sobota, 9000

  • Site SI38602 General Hospital Novo Mesto

    Novo Mesto, 8000

Other trials in Slovenia

Greece1 site

  • Site GR30009 Aretaieio/Maginio

    Athens, 115 28

Other trials in Greece

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Being tested
Solifenacin succinate, Mirabegron, Placebo to match solifenacin succinate, Placebo to match mirabegron
Keywords
Combination Therapy, Mirabegron, Overactive Bladder, Urgency, Urinary Incontinence, Nocturia, Solifenacin Succinate
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence, Nocturia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solifenacin succinateDrug

    Also called Vesikur, Vesitrim, YM905, Vesicare

    Oral tablet

  • MirabegronDrug

    Also called YM178, Betmiga, Betanis, Myrbetriq

    Oral tablet

  • Placebo to match solifenacin succinateDrug

    Oral tablet

  • Placebo to match mirabegronDrug

    Oral tablet

Study groups in NCT01972841
Study groupRoleWhat they receive
1: Solifenacin 5 mg + Mirabegron 25 mgExperimentalParticipants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
Receives: Drug: Solifenacin succinate; Drug: Mirabegron; Drug: Placebo to match mirabegron
2: Solifenacin 5 mg + Mirabegron 50 mgExperimentalParticipants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Receives: Drug: Solifenacin succinate; Drug: Mirabegron; Drug: Placebo to match mirabegron
3: PlaceboPlacebo comparatorParticipants who received matching placebo once a day for 12 weeks.
Receives: Drug: Placebo to match solifenacin succinate; Drug: Placebo to match mirabegron
4: Solifenacin 5 mgActive comparatorParticipants who received solifenacin 5 mg once a day for 12 weeks.
Receives: Drug: Solifenacin succinate; Drug: Placebo to match mirabegron
5:Mirabegron 25 mgActive comparatorParticipants who received mirabegron 25 mg once a day for 12 weeks.
Receives: Drug: Mirabegron; Drug: Placebo to match solifenacin succinate; Drug: Placebo to match mirabegron
6: Mirabegron 50 mgActive comparatorParticipants who received mirabegron 50 mg once a day for 12 weeks.
Receives: Drug: Mirabegron; Drug: Placebo to match solifenacin succinate; Drug: Placebo to match mirabegron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

    Measured: Baseline and EoT (up to 12 weeks)

  2. Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours

    A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

    Measured: Baseline and EoT (up to 12 weeks)

Secondary outcomes (68)

  1. Change From Baseline to EoT in Mean Volume Voided Per Micturition

    The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.

    Measured: Baseline and EoT (up to 12 weeks)

  2. Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

    The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.

    Measured: Baseline and EoT (up to 12 weeks)

  3. Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

    The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.

    Measured: Baseline and EoT (up to 12 weeks)

  4. Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT

    The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  5. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  6. Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

    Measured: Baseline and weeks 4, 8 and 12

  7. Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours

    Measured: Baseline and weeks 4, 8 and 12

  8. Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition

    Measured: Baseline and weeks 4, 8 and 12

  9. Change From Baseline to EoT in Corrected Micturition Frequency

    Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.

    Measured: Baseline and Week 12

  10. Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT

    An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  11. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  12. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

    The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  13. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

    An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  14. Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT

    A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  15. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes

    Measured: Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)

  16. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

    The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  17. Number of Pads Used at Weeks 4, 8, 12 and EoT

    The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.

    Measured: Weeks 4, 8 and 12 (up to 12 weeks)

  18. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used

    Measured: Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)

  19. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours

    The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

    Measured: Baseline and weeks 4, 8 and 12 (up to 12 weeks)

  20. Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT

    The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  21. Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

    The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.

    Measured: Weeks 4, 8,12 and EoT (up to 12 weeks)

  22. Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

    The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  23. Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)

    The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.

    Measured: Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)

  24. Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score

    The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.

    Measured: Baseline and weeks 4, 8 and 12

  25. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score

    The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  26. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping

    The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  27. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern

    The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  28. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep

    The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  29. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social

    The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  30. Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT

    The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).

    Measured: Week 12 and EoT (up to 12 weeks)

  31. PGIC Scale: Impression in General Health at Week 12 and EoT

    The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).

    Measured: Week 12 and EoT (up to 12 weeks)

  32. Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility

    The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

    Measured: Baseline and EoT (up to 12 weeks)

  33. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care

    The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

    Measured: Baseline and EoT (up to 12 weeks)

  34. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities

    The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

    Measured: Baseline and EoT (up to 12 weeks)

  35. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort

    The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

    Measured: Baseline and EoT (up to 12 weeks)

  36. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression

    The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

    Measured: Baseline and EoT (up to 12 weeks)

  37. Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

    The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.

    Measured: Baseline and week 12 and EoT (up to 12 weeks)

  38. Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

    Measured: Baseline and week 12 and EoT (up to 12 weeks)

  39. Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment

    Measured: Baseline and week 12 and EoT (up to 12 weeks)

  40. Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment

    Measured: Baseline and week 12 and EoT (up to 12 weeks)

  41. Change From Baseline to Weeks 4, 8 and 12 in TS-VAS

    The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.

    Measured: Baseline and week 4, 8 and 12

  42. Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT

    The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  43. Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT

    The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  44. Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT

    The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  45. Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT

    The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  46. Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT

    The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8 , 12 and EoT (up to 12 weeks)

  47. Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT

    The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  48. Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

    The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  49. Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

    The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  50. Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT

    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  51. Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT

    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  52. Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  53. Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

    The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  54. Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

    The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

    Measured: Weeks 4, 8, 12 and EoT (up to 12 weeks)

  55. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.

    Measured: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)

  56. Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume

    PVR volume was assessed by ultrasonography or a bladder scanner.

    Measured: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

  57. Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)

    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  58. Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)

    Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  59. Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  60. Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  61. Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  62. Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  63. Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  64. Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  65. Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  66. Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  67. Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

  68. Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference

    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

    Measured: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2013 (estimated)
  2. Study start5 Nov 2013
  3. Primary completion22 Oct 2015
  4. Study completion22 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,527 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01972841
Sponsor's protocol ID
178-CL-101
Other IDs
2012-005735-91, U1111-1153-9095
Acronym
SYNERGY
Status last verified
Oct 2024
First submitted
25 Oct 2013
Last updated
31 Oct 2024
Data monitoring committee
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

    PubMed 37160401

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Solifenacin succinate and Mirabegron in people with Urinary Bladder Overactive and Urinary Bladder Diseases\Urologic Diseases, run by Astellas Pharma Europe B.V. at 435 sites in 42 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 435 sites in United States, Canada, South Korea, China, Australia and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours (time frame: Baseline and EoT (up to 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01972841, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in