AzTrials
AzTrials

Cardiovascular Disease, Diabetes Mellitus Type 2Phase 3NCT01715818

A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

A Phase 3 study testing aleglitazar in people with Cardiovascular Disease, Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 392 sites in 27 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

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
aleglitazar
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,999 participants
Where
392 sitesin 27 countries
Study dates
Dec 2012to Nov 2013
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
  • Patients with glucose abnormalities based on one of the following A-B criteria:
  • Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities
  • Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Who cannot join

  • Current treatment with a thiazolidinedione (TDZ) or fibrate
  • Prior intolerance to a TDZ or fibrate
  • Previous participation in a trial with aleglitazar
  • Other types of diabetes
  • Inadequate liver, hematologic or renal function
  • Symptomatic heart failure classified as NYHA class II-IV
Show all 12Show fewer
  • Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
  • Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
  • History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
  • Currently scheduled for arterial revascularization procedures
  • Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening
  • Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years

Trial locations and contacts

392 sites in 27 countries.

392 sites in 27 countries

United States143 sites

  • Study site

    Akron, Ohio, 44313

  • Study site

    Albany, New York, 12206-1098

  • Study site

    Alexandria, Louisiana, 71301

  • Study site

    Arlington, Texas, 76012

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Bangor, Maine, 04401

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bellevue, Nebraska, 68005

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Bradenton, Florida, 34208

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Brownsburg, Indiana, 46112

  • Study site

    Burke, Virginia, 22015

  • Study site

    Chattanooga, Tennessee, 37404-3230

  • Study site

    Chattanooga, Tennessee, 37411

  • Study site

    Clearwater, Florida, 33755

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Clinton, South Carolina, 29325

  • Study site

    Corpus Christi, Texas, 78404

  • Study site

    Council Bluffs, Iowa, 51501

  • Study site

    Cudahy, California, 90201

  • Study site

    Dakota Dunes, South Dakota, 57049

  • Study site

    Dallas, Texas, 75230

  • Study site

    Decatur, Georgia, 30030

  • Study site

    DeLand, Florida, 32720

  • Study site

    Denver, Colorado, 80209

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Draper, Utah, 84020

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Eagle, Idaho, 83616

  • Study site

    El Paso, Texas, 79925

  • Study site

    Elizabeth, New Jersey, 07202

  • Study site

    Elizabeth City, North Carolina, 27909

  • Study site

    Encino, California, 91436

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fall Rivers, Mississippi, 02720

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fleetwood, Pennsylvania, 19522

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Fremont, Nebraska, 68025

  • Study site

    Fresno, California, 93720

  • Study site

    Fresno, California, 93721

  • Study site

    Gallipolis, Ohio, 45631

  • Study site

    Gilbert, Arizona, 85295

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Harleysville, Pennsylvania, 19438

  • Study site

    Haverhill, Massachusetts, 01830

  • Study site

    Hawaiian Gardens, California, 90716

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33013

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77036

  • Study site

    Houston, Texas, 77074

  • Study site

    Huntington Beach, California, 92646

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jersey Shore, Pennsylvania, 17740

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Kingwood, Texas, 77339

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Knoxville, Tennessee, 27912

  • Study site

    Lansdale, Pennsylvania, 19446

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Las Vegas, Nevada, 89121

  • Study site

    Las Vegas, Nevada, 89123

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Lomita, California, 90717

  • Study site

    Long Beach, California, 90807

  • Study site

    Los Angeles, California, 90017

  • Study site

    Los Angeles, California, 90036

  • Study site

    Los Angeles, California, 90057

  • Study site

    Los Gatos, California, 95032

  • Study site

    Louisville, Kentucky, 40213

  • Study site

    Madison, Wisconsin, 53719

  • Study site

    Manassas, Virginia, 20110

  • Study site

    McAllen, Texas, 78501

  • Study site

    Melrose Park, Illinois, 60160

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33144

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Morganton, North Carolina, 28655

  • Study site

    Murray, Utah, 84123

  • Study site

    Murrells Inlet, South Carolina, 29576

  • Study site

    Muscle Shoals, Alabama, 35662

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Braunfels, Texas, 78130

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    North Hollywood, California, 91606

  • Study site

    North Massapequa, New York, 11758

  • Study site

    North Richland Hills, Texas, 76180

  • Study site

    Northridge, California, 91325

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Orlando, Florida, 32822

  • Study site

    Owensboro, Kentucky, 42303

  • Study site

    Oxon Hill, Maryland, 20745

  • Study site

    Panama City, Florida, 32401

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Phoenix, Arizona, 85018

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Pittsburgh, Pennsylvania, 15202

  • Study site

    Port Charlotte, Florida, 33952

  • Study site

    Port Orchard, Washington, 98366

  • Study site

    Portland, Oregon, 97220

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Roseville, California, 95661

  • Study site

    Sacramento, California, 95821

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    San Antonio, Texas, 78224

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Shelby, North Carolina, 28150

  • Study site

    Smithtown, New York, 11787

  • Study site

    Spokane, Washington, 99207

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Stockton, California, 95207

  • Study site

    Suffolk, Virginia, 23435

  • Study site

    Syracuse, New York, 13202

  • Study site

    Tampa, Florida, 33613

  • Study site

    Thousand Oaks, California, 91360

  • Study site

    Torrance, California, 90502

  • Study site

    Traverse City, Michigan, 49684

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tustin, California, 92780

  • Study site

    Tyler, Texas, 75701

  • Study site

    Uniontown, Pennsylvania, 15401

  • Study site

    Valparaiso, Indiana, 46383

  • Study site

    Varnville, South Carolina, 29944

  • Study site

    Ventura, California, 90265

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Westfield, New York, 14787

  • Study site

    Wichita, Kansas, 67203

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Park, Florida, 32789

  • Study site

    Zanesville, Ohio, 43701

Other trials in United States

Canada35 sites

  • Study site

    Bathurst, New Brunswick, E2A 4X7

  • Study site

    Cambridge, Ontario, N1R 6V6

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Chicoutimi, Quebec, G7H 7Y8

  • Study site

    Collingwood, Ontario, L9Y 1W3

  • Study site

    Granby, Quebec, J2G 8Z9

  • Study site

    Greater Sudbury, Ontario, P3C 5K7

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Kelowna, British Columbia, V1Y 1E4

  • Study site

    Lachine, Quebec, H8S 2E4

  • Study site

    Laval, Quebec, H7M 3L9

  • Study site

    London, Ontario, N5W 6A2

  • Study site

    London, Ontario, N6G 0J4

  • Study site

    Longueuil, Quebec, J4M 2X1

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H1T 3Y7

  • Study site

    Montreal, Quebec, H2P 2M1

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Montreal, Quebec, H4N 2W2

  • Study site

    Newmarket, Ontario, L3Y 5G8

  • Study site

    Newmarket, Ontario, L3Y 8C3

  • Study site

    Quebec, Prince Edward Island, G1V 4G2

  • Study site

    Québec, Quebec, G3K 2P8

  • Study site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    Saint-Lambert, Quebec, J4P 2H4

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    Saskatoon, Saskatchewan, S7K 3H3

  • Study site

    Sherbrooke, Quebec, J1H 5N4

  • Study site

    Ste-Foy, Quebec, G1W 4R4

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Terrebonne, Quebec, J6V 1S8

  • Study site

    Toronto, Ontario, M5G 2C4

  • Study site

    Toronto, Ontario, M9V 4B4

  • Study site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Spain22 sites

  • Study site

    Albacete, Albacete, 02006

  • Study site

    Almería, Almeria, 04009

  • Study site

    Alzira, Valencia, 46600

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Barcelona, Barcelona

  • Study site

    Girona, Girona, 17007

  • Study site

    Granada, Granada, 18012

  • Study site

    Huelva, Huelva, 21005

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Lleida, Lerida, 25198

  • Study site

    Madrid, Madrid, 41013

  • Study site

    Málaga, Malaga, 29006

  • Study site

    Málaga, Malaga, 29009

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Palma de Mallorca, Balearic Islands, 07014

  • Study site

    Sant Joan d'Alacant, Alicante, 3550

  • Study site

    Santiago de Compostela, La Coruña, 15706

  • Study site

    Seville, Sevilla, 41009

  • Study site

    Tarragona, Tarragona, 43007

  • Study site

    Valencia, Valencia, 46014

Other trials in Spain

Germany20 sites

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 13125

  • Study site

    Bochum, 44787

  • Study site

    Charlottenburg, 14050

  • Study site

    Chemnitz, 09111

  • Study site

    Cologne, 50937

  • Study site

    Damme, 49401

  • Study site

    Dresden, 01067

  • Study site

    Frankfurt, 60596

  • Study site

    Frankfurt, 65929

  • Study site

    Hanover, 30159

  • Study site

    Homburg/Saar, 66421

  • Study site

    Kassel, 34121

  • Study site

    Köthen, 06366

  • Study site

    Leipzig, 04103

  • Study site

    Magdeburg, 39104

  • Study site

    Mönchengladbach, 41063

  • Study site

    Münster, 48145

  • Study site

    Neunkirchen, 66539

  • Study site

    Wangen, 88239

Other trials in Germany

Hungary17 sites

  • Study site

    Balatonfüred, 8230

  • Study site

    Budapest, 1023

  • Study site

    Budapest, 1027

  • Study site

    Budapest, 1036

  • Study site

    Budapest, 1085

  • Study site

    Budapest, 1097

  • Study site

    Budapest, 1125

  • Study site

    Budapest, 1131

  • Study site

    Debrecen, 4032

  • Study site

    Gyöngyös, 3200

  • Study site

    Mosonmagyaróvár, 9200

  • Study site

    Nyíregyháza, 4400

  • Study site

    Pápa, 8500

  • Study site

    Szeged, 6720

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szolnok, 5004

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Poland17 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Gdynia, 81-384

  • Study site

    Gdynia, 81-472

  • Study site

    Katowice, 40-748

  • Study site

    Katowice, 40-954

  • Study site

    Krakow, 30-015

  • Study site

    Krakow, 30-082

  • Study site

    Krakow, 31-202

  • Study site

    Krakow, 31-261

  • Study site

    Lodz, 90-242

  • Study site

    Lublin, 20-044

  • Study site

    Lublin, 20-093

  • Study site

    Nowy Sącz, 33-300

  • Study site

    Opole, 45-367

  • Study site

    Rzeszów, 35-055

  • Study site

    Warsaw, 01-192

  • Study site

    Wroclaw, 50-088

Other trials in Poland

South Korea17 sites

  • Study site

    Busan, 602-715

  • Study site

    Busan, 602-739

  • Study site

    Daejeon, 35015

  • Study site

    Gwangju, 61469

  • Study site

    Gyeonggi-do, 10380

  • Study site

    Gyeonggi-do, 11765

  • Study site

    Gyeonggi-do, 410-773

  • Study site

    Gyeonggi-do, 431-070

  • Study site

    Gyeonggi-do, 443-380

  • Study site

    Incheon, 405-760

  • Study site

    Seoul, 05030

  • Study site

    Seoul, 06273

  • Study site

    Seoul, 130-872

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 156-707

  • Study site

    Suwon, 442-723

  • Study site

    Wŏnju, 220-701

Other trials in South Korea

Czechia16 sites

  • Study site

    Beroun, 266 01

  • Study site

    Brno, 601 77

  • Study site

    Brno, 625 00

  • Study site

    Jihlava, 586 33

  • Study site

    Liberec, 460 63

  • Study site

    Prague, 100 34

  • Study site

    Prague, 128 08

  • Study site

    Prague, 140 21

  • Study site

    Prague, 140 59

  • Study site

    Prague, 149 00

  • Study site

    Prague, 150 06

  • Study site

    Prague, 150 30

  • Study site

    Prague, 158 00

  • Study site

    Praha 4 - Krc, 140 59

  • Study site

    Slaný, 274 51

  • Study site

    Třebíč, 674 01

Other trials in Czechia

Australia13 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Armadale, Western Australia, 6112

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Gosford, New South Wales, 2250

  • Study site

    Heidelberg, Victoria, 3081

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Launceston, Tasmania, 7250

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Perth, Western Australia, 6009

  • Study site

    South Brisbane, Queensland, 4101

  • Study site

    Wollongong, New South Wales, 2500

  • Study site

    Woodville, South Australia, 5011

Other trials in Australia

United Kingdom13 sites

  • Study site

    Birmingham, B15 2SQ

  • Study site

    Cardiff, CF14 5GJ

  • Study site

    Chorley, PR7 7NA

  • Study site

    Edinburgh, EH16 4TJ

  • Study site

    Glasgow, G12 8QQ

  • Study site

    Glasgow, G20 0SP

  • Study site

    Inverness, IV2 4AG

  • Study site

    Liverpool, L22 0LG

  • Study site

    Liverpool, L9 7AL

  • Study site

    Manchester, M15 6SX

  • Study site

    Mortimer, RG7 3SQ

  • Study site

    Reading, RG2 0TG

  • Study site

    Soham, Ely, CB7 5JD

Other trials in United Kingdom

Italy12 sites

  • Study site

    Bologna, Emilia-Romagna, 40133

  • Study site

    Catania, Sicily, 95122

  • Study site

    Massa, Tuscany, 54100

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20138

  • Study site

    Naples, Campania, 80122

  • Study site

    Naples, Campania, 80131

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Pesaro, The Marches, 61121

  • Study site

    Rome, Lazio, 00128

  • Study site

    Rome, Lazio, 00185

Other trials in Italy

Romania11 sites

  • Study site

    Baia Mare, 430123

  • Study site

    Bucharest, 010507

  • Study site

    Bucharest, 010825

  • Study site

    Bucharest, 020359

  • Study site

    Bucharest, 050098

  • Study site

    Bucharest, 061119

  • Study site

    Bucharest, 800578

  • Study site

    Craiova, 200642

  • Study site

    Oradea, 410169

  • Study site

    Ploieşti, 100163

  • Study site

    Târgu Mureş, 540124

Other trials in Romania

Chile7 sites

  • Study site

    Las Condes, 7500710

  • Study site

    Santiago, 7500010

  • Study site

    Santiago, 7500347

  • Study site

    Santiago, 7500710

  • Study site

    Temuco, 4781156

  • Study site

    Temuco, 4790869

  • Study site

    Temuco, 4813299

Other trials in Chile

Colombia6 sites

  • Study site

    Barranquila

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Cartagena

  • Study site

    Floridablanca

  • Study site

    Medellín

Other trials in Colombia

Malaysia6 sites

  • Study site

    Johor Bahru, 80100

  • Study site

    Kuala Lumpur, 59100

  • Study site

    Kuala Selangor, 68100

  • Study site

    Perak, 34000

  • Study site

    Sabak Bernam, 88300

  • Study site

    Sarawak, 94300

Other trials in Malaysia

Latvia5 sites

  • Study site

    Liepāja, 3400

  • Study site

    Riga, LV-1002

  • Study site

    Riga, LV-1012

  • Study site

    Riga, LV-1024

  • Study site

    Riga, LV-1058

Other trials in Latvia

Mexico5 sites

  • Study site

    Aguascalientes, 20234

  • Study site

    México, 03300

  • Study site

    Monclova, 25750

  • Study site

    Monterrey, 64460

  • Study site

    Xalapa, 91020

Other trials in Mexico

Austria4 sites

  • Study site

    Braunau am Inn, 5280

  • Study site

    Feldkirch, 6800

  • Study site

    Graz, 8036

  • Study site

    Vienna, 1130

Other trials in Austria

Estonia4 sites

  • Study site

    Narva, 20307

  • Study site

    Tallinn, 10138

  • Study site

    Tartu, 50410

  • Study site

    Tartu, 51014

Other trials in Estonia

Lithuania4 sites

  • Study site

    Kaunas, 48259

  • Study site

    Kaunas, 50184

  • Study site

    Kaunas, LT-47144

  • Study site

    Vilnius, LT-02169

Other trials in Lithuania

Sweden4 sites

  • Study site

    Malmö, 205 02

  • Study site

    Stockholm, 111 35

  • Study site

    Stockholm, 113 61

  • Study site

    Stockholm, 171 76

Other trials in Sweden

Russia3 sites

  • Study site

    Kemerovo

  • Study site

    Saint Petersburg, 199034

  • Study site

    Tomsk, 634012

Other trials in Russia

Argentina2 sites

  • Study site

    Caba, C1119ACN

  • Study site

    Caba, C1428DCO

Other trials in Argentina

South Africa2 sites

  • Study site

    Pretoria, 0103

  • Study site

    Pretoria West, 0183

Other trials in South Africa

Thailand2 sites

  • Study site

    Bangkok, 10330

  • Study site

    Khon Kaen, 40002

Other trials in Thailand

Israel1 site

  • Study site

    Giv‘atayim, 53583

Other trials in Israel

Japan1 site

  • Study site

    Tochigi, 329-0498

Other trials in Japan

About this study

Official title: A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.

Being tested
Placebo, aleglitazar
Medical subject headings
Cardiovascular Diseases, Diabetes Mellitus, Type 2

What participants receive

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

  • PlaceboDrug

    matching aleglitazar placebo tablet orally daily

  • aleglitazarDrug

    150 mcg orally daily

Study groups in NCT01715818
Study groupRoleWhat they receive
AleglitazarExperimentalNot described
Receives: Drug: aleglitazar
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC)

    Measured: 5 years

Secondary outcomes (2)

  1. Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)

    Measured: 5 years

  2. Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)

    Measured: 5 years

Timeline

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

  1. First posted29 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

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
1,999 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715818
Sponsor's protocol ID
BC28027
Other IDs
2012-000671-16
Status last verified
Nov 2016
First submitted
25 Oct 2012
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aleglitazar in people with Cardiovascular Disease, Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 392 sites in 27 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 4 inclusion and 12 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 392 sites in United States, Canada, Spain, Germany, Hungary and 22 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC) (time frame: 5 years). 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 NCT01715818.

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 2 Nov 2016.

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