AzTrials
AzTrials

Benign Prostatic HyperplasiaPhase 4PLUSNCT02757768

A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

A Phase 4 study testing Mirabegron and Tamsulosin Hydrochloride in people with Benign Prostatic Hyperplasia and Overactive Bladder, run by Astellas Pharma Global Development, Inc. at 79 sites in 9 countries.

Completed

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

Official record
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Trial summary

The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH). Read more about this study

Who is it for?
Ages 40 years and older, men only
What is being tested?
Mirabegron and Tamsulosin Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
715 participants
Where
79 sitesin 9 countries
Study dates
13 Jun 2016to 11 Sep 2018
Phase
Phase 4
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 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men ≥40 years of age with history of overactive bladder (OAB) symptoms (frequency of ≥8 micturitions per day and urgency episodes of ≥2 per day) while taking tamsulosin hydrochloride for at least 2 months to treat LUTS due to BPH.
  • Subject has symptoms of OAB (urinary frequency and urgency with or without incontinence) for ≥3 months prior to Screening.
  • Subject has an International Prostate Symptom Score (IPSS) score ≥8.
  • Subject has Prostate-Specific Antigen (PSA) <4 ng/mL or ≥4 but < 10 ng/mL with a prostate biopsy that is negative for cancer in the past 2 years.
  • Subject is willing and able to complete the 3-day diary (including urine volumes, vital signs measurements), and Quality of Life questionnaires.
  • Subject and the subject's spouses/partners who are of childbearing potential must be using a highly effective birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS). Birth control must be practiced from Screening and continue throughout the study and for 30 days after the final study drug administration. In addition, sperm donation will not be allowed throughout the study and for 30 days after the final study drug administration.
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  • Subject agrees not to participate in another interventional study while on treatment.
  • Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
  • Subject continues to meet all inclusion criteria of Visit 1 (Screening).
  • Subject must experience an average of 8 or more micturitions per day over the 3-day diary period.
  • Subject must experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-diary period

Who cannot join

  • Subject has post-void residual volume (PVR) >200 mL.
  • Subject has maximum urinary flow (Qmax) <5.0 mL/second with a minimum voided volume of 125 mL.
  • Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
  • Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, nitrites, or turbidity and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI, at Screening (Visit 1) the subject may be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
  • Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson's, etc.).
  • Subject has diabetic neuropathy.
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  • Previous open, robotic or minimally invasive prostate surgery (including transurethral procedures). Planned (scheduled) pelvic or prostate surgery during the study period.
  • Planned (scheduled) cataract surgery.
  • Subject with significant stress incontinence
  • Subject with clinically significant bladder outlet obstruction.
  • Subject has an indwelling catheter or practices intermittent self-catheterization.
  • Subject has experienced 3 or more episodes of recurrent urinary tract infection within the last 12 months.
  • Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder, prostate and rectum; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs such as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen).
  • Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
  • Subject has ever received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
  • Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening.
  • Subject has postural hypotension or syncope or postural orthostatic tachycardia.
  • Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
  • Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min/1.73 m2 as determined by hospital laboratory calculation of eGFR. A subject with End Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for the study.
  • Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
  • Subject has baseline resting pulse rate <60 BPM or >90 BPM.
  • Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2) electrocardiogram (ECG) defined as QTcF >450 msec.
  • Subject has any clinically significant ECG abnormality.
  • Subject has AST or ALT >2x upper limit of normal (ULN), or γ-GT >3x ULN and considered clinically significant.
  • Subject has a hypersensitivity to any components of mirabegron, tamsulosin hydrochloride, or any of the inactive ingredients.
  • Subject has a history of angioedema.
  • Subject has any clinical significant condition which makes the subject unsuitable for study participation.
  • Subject has been treated with an experimental device within 28 days or received an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.
  • Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
  • Subject has ongoing alcohol and/or drug abuse.
  • Subject is using prohibited medications within 30 days prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
  • Subject has stopped, started or changed the dose of a restricted medication within the 30 days prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6)
  • Subject has participated in an interventional trial within 30 days prior to Screening (Visit 1).
  • Subject is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team.
  • Subject has previously received mirabegron in the 6 months prior to Screening (Visit 1).
  • Subject was non-compliant during the 4-week tamsulosin hydrochloride run-in period, defined as taking less than 80% or greater than 120% of study medication.
  • Subject had an average total daily urine volume >3000 mL as recorded in the 3-day diary.

Trial locations and contacts

79 sites in 9 countries.

79 sites in 9 countries

United States32 sites

  • Site US01031

    Albuquerque, New Mexico, 87109

  • Site US01012

    Anchorage, Alaska, 99503

  • Site US01041

    Baltimore, Maryland, 21287

  • Site US01067

    Billings, Montana, 59102

  • Site US01016

    Boston, Massachusetts, 02131

  • Site US01072

    Bristol, Tennessee, 37620

  • Site US01069

    Cary, North Carolina, 25711

  • Site US01042

    Clarksville, Tennessee, 37043

  • Site US01029

    Edison, New Jersey, 08837

  • Site US01097

    Englewood, Colorado, 80113

  • Site US01015

    Garden City, New York, 11530

  • Site US01070

    Hawaiian Gardens, California, 90712

  • Site US01009

    Homewood, Alabama, 35209

  • Site US01005

    Huntsville, Alabama, 35749

  • Site US01060

    Kansas City, Missouri, 64116

  • Site US01056

    Knoxville, Tennessee, 37909

  • Site US01075

    Knoxville, Tennessee, 37912

  • Site US01078

    Knoxville, Tennessee, 37938

  • Site US01081

    Los Angeles, California, 90035

  • Site US01079

    Maiden, North Carolina, 28650

  • Site US01021

    Murrieta, California, 92562

  • Site US01063

    Newport News, Virginia, 23606

  • Site US01061

    Omaha, Nebraska, 68114

  • Site US01019

    Plainview, New York, 11803

  • Site US01026

    Pompano Beach, Florida, 33060

  • Site US01068

    San Diego, California, 92120

  • Site US01094

    Shreveport, Louisiana, 71106

  • Site US01025

    St. Petersburg, Florida, 33710

  • Site US01064

    Valley Village, California, 91607

  • Site US01003

    Watertown, Massachusetts, 02472

  • Site US01027

    Wellington, Florida, 33449

  • Site US01034

    West Des Moines, Iowa, 50266

Other trials in United States

Canada8 sites

  • Site CA15003

    Barrie, Ontario, L4M 7G1

  • Site CA15001

    Brampton, Ontario, L6T 4S5

  • Site CA15008

    Calgary, Alberta, T2V 1P9

  • Site CA15011

    Québec, Quebec, G1N 4V3

  • Site CA15002

    Sherbrooke, Quebec, J1H 5N4

  • Site CA15009

    Sherbrooke, Quebec, J1L 0H8

  • Site CA15005

    Toronto, Ontario, M4N 3M5

  • Site CA15014

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Italy8 sites

  • Site IT39002

    Avellino, 83100

  • Site IT39003

    Catanzaro, 88100

  • Site IT39010

    Chieti, 66013

  • Site IT39004

    Florence, 50139

  • Site IT39005

    Latina, 04100

  • Site IT39006

    Pisa, 56124

  • Site IT39001

    Treviglio, 24047

  • Site IT39008

    Vasto, 66054

Other trials in Italy

Germany7 sites

  • Site DE49002

    Duisburg, 47051

  • Site DE49003

    Eisleben Lutherstadt, 06295

  • Site DE49001

    Hagenow, 19230

  • Site DE49006

    Halle, 06132

  • Site DE49004

    Hamburg, D-22303

  • Site DE49005

    Hettstedt, 06333

  • Site DE49007

    Sangerhausen, 06526

Other trials in Germany

Spain7 sites

  • Site ES34007

    Barcelona, 08003

  • Site ES34009

    Lugo, 27003

  • Site ES34001

    Madrid, 28031

  • Site ES34003

    Miranda de Ebro, 09200

  • Site ES34002

    Seville, 41014

  • Site ES34006

    Valencia, 46014

  • Site ES34004

    Vigo, 36211

Other trials in Spain

Czechia5 sites

  • Site CZ42004

    Benešov, 256 01

  • Site CZ42006

    Domažlice, 339 01

  • Site CZ42005

    Prague, 101 00

  • Site CZ42003

    Prague, 140 00

  • Site CZ42001

    Sternberk, 78501

Other trials in Czechia

Poland5 sites

  • Site PL48006

    Katowice, 40-611

  • Site PL48001

    Piaseczno, 05-500

  • Site PL48004

    Warsaw, 02-797

  • Site PL48005

    Wroclaw, 53-114

  • Site PL48007

    Wroclaw, 53-329

Other trials in Poland

United Kingdom5 sites

  • Site GB44005

    Bristol, BS10 5NB

  • Site GB44011

    Bristol, BS48 3HA

  • Site GB44004

    Newcastle upon Tyne, NE7 7DN

  • Site GB44002

    Reading, RG1 5AN

  • Site GB44006

    York, YO31 8HE

Other trials in United Kingdom

France2 sites

  • Site FR33004

    Colmar, 68024

  • Site FR33002

    Pierre-Bénite, 69495

Other trials in France

About this study

Official title: A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).

Read the detailed description

At Screening (Visit 1), participants entered into a 4-week open label tamsulosin hydrochloride 0.4 mg QD run-in period prior to being randomized into the 12-week double-blind treatment period (Visit 2). At conclusion of the 4-week tamsulosin hydrochloride run-in period, participants completed a 3-day diary just prior to Baseline (Visit 2). Approximately 7 days prior to Visit 2 participants received a phone call reminding them about the diary and to answer any questions.

If participants met all entry criteria at the end of the tamsulosin hydrochloride run-in period, participants were randomized to 1 of 2 treatment groups (mirabegron or placebo) for 12 weeks of treatment in addition to the continuation of tamsulosin hydrochloride 0.4 mg QD. Those participants randomized to Mirabegron started at 25 mg and increased to 50 mg after 4 weeks. Those participants randomized to placebo started blinded product matched to the mirabegron 25 mg tablet and increased to blinded product matched to 50 mirabegron after 4 weeks. Once a participant increased dose, the participant remained on that dose for the remainder of the study unless for safety reasons was required to discontinue study drug.

A training diary was completed in the first 2 weeks of the tamsulosin hydrochloride run-in period. During this evaluation period at least one telephone contact took place with the participant. Diaries were completed at home, using the electronic patient-reported outcome (ePRO) device, for 3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). Site staff contacted the participant approximately 7 days prior to the scheduled visit to remind the participant to complete the electronic diary, review completion instruction and review changes to concomitant medications and adverse events (if applicable).

Three days before Visits 2 (Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12), participants completed a 3-day diary, using the ePRO device in which the participant recorded micturition frequency, urgency (PPIUS), incontinence and volume voided. In addition, the diary captured morning and evening blood pressure and pulse rate measurements via Home Blood Pressure Monitoring (HBPM). At Visit 1, International Prostate Symptom Score (IPSS) was completed. At Visits 2, 3, 4, and 5, participants completed the IPSS, EQ-5D-5L, OAB-q, PPBC, and TS-VAS. Maximum urinary flow (Qmax) was measured at Visit 1 (Screening/tamsulosin hydrochloride run-in) and Visit 5 (Week 12/End of Treatment). Post-void residual volume (PVR) was assessed at Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2) and at Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). A follow-up phone call (Visit 6) was conducted 4-weeks after End of Treatment (Visit 5). Total study participation was approximately 20 weeks.

Being tested
Mirabegron, Placebo, Tamsulosin Hydrochloride
Keywords
Myrbetriq, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Overactive Bladder, Betmiga, Mirabegron, Tamsulosin Hydrochloride
Medical subject headings
Prostatic Hyperplasia, Urinary Bladder, Overactive, Lower Urinary Tract Symptoms

What participants receive

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

  • MirabegronDrug

    Also called Myrbetriq, Betmiga, YM178

    Participants received initial dose of 25 mg of mirabegron (oral tablet) which was increased to 50 mg after 4 weeks.

  • PlaceboDrug

    Participants received initial dose of 25 mg of matching placebo (oral tablet) which was increased to 50 mg after 4 weeks.

  • Tamsulosin HydrochlorideDrug

    Also called Flomax, Omnic

    Participants received once daily treatment with tamsulosin hydrochloride 0.4 mg (oral tablet) throughout the study.

Study groups in NCT02757768
Study groupRoleWhat they receive
MirabegronExperimentalParticipants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
Receives: Drug: Mirabegron; Drug: Tamsulosin Hydrochloride
PlaceboPlacebo comparatorParticipants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
Receives: Drug: Placebo; Drug: Tamsulosin Hydrochloride

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 Micturitions Per Day

    Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.

    Measured: Baseline and Week 12

Secondary outcomes (20)

  1. Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day

    Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.

    Measured: Baseline and Weeks 4, 8, and 12

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

    The mean volume voided per micturition during 3 days of the 3-day micturition diary period.

    Measured: Baseline and Weeks 4, 8, and 12

  3. Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day

    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 as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.

    Measured: Baseline and Weeks 4, 8, and 12

  4. Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day

    Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.

    Measured: Baseline and Weeks 4, 8, and 12

  5. Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score

    The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The IPSS total score classification ranges from mild (0 to 7) to moderate (8 to 19) or severe (20 to 35). Higher IPSS scored indicated more severe symptoms.

    Measured: Baseline and Weeks 4, 8, and 12

  6. Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score

    The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). The lowest and highest possible scores range from 0 to 20 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.

    Measured: Baseline and Weeks 4, 8, and 12

  7. Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score

    The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). The lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.

    Measured: Baseline and Weeks 4, 8, and 12

  8. Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score

    The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.

    Measured: Baseline and Weeks 4, 8, and 12

  9. Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day

    Urgency Incontinence was defined as the complaint of involuntary leakage accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.

    Measured: Baseline and Weeks 4, 8 and 12

  10. Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score

    Overactive bladder symptoms were assessed using the Symptom Bother Scale of the Overactive Bladder questionnaire (OAB-q). The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, 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). Lower scores on OAB-q symptom bother indicate a better response.

    Measured: Baseline and Weeks 4, 8, and 12

  11. Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score

    The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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 higher score on OAB-q HRQL indicated a better response.

    Measured: Baseline and Weeks 4, 8, and 12

  12. Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score

    The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Coping subscale ranges from 8 to 48. The Coping score was calculated by adding the 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, and 12

  13. Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score

    The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Concern subscale ranges from 7 to 42. The Concern score was calculated by adding the 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, and 12

  14. Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score

    The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Sleep subscale ranges from 5 to 30. The Sleep score was calculated by adding the 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 and 12

  15. Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score

    The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Social Interaction subscale ranges from 5 to 30. The Social Interaction score was calculated by adding the 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, and 12

  16. Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities

    The EQ-5D-5L is an international standardized non-disease specific generic instrument for describing and valuing health status. It has a multidimensional measure of health-related QoL, capable of being expressed as a single index value and specifically designed to complement other health status measures. The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels (e.g., 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the activity). Health-state utility (HSU) data are estimates of the preference for a given state of health on a cardinal numeric scale, where a value of 1.0 represents full health, 0.0 represents dead, and negative values represent states worse than death. Missing EoT values were imputed using LOCF method.

    Measured: Baseline and Weeks 4, 8, and 12

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

    The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate 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. A higher score indicated a worse perception of bladder condition.

    Measured: Baseline and Weeks 4, 8, and 12

  18. Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)

    The TUFS was calculated by adding the PPIUS scores of every void in a participant's 3-day diary, and dividing this by the number of days recorded in the diary. Due to a programming failure in the e-diary data for the number of pads used was not collected.

    Measured: Baseline and Weeks 4, 8 and 12

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

    A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence is not considered a nocturia episode. The mean number of nocturia episodes per day (24 hours) was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.

    Measured: Baseline and Weeks 4, 8, and 12

  20. Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)

    The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).

    Measured: Baseline and Weeks 4, 8, and 12

Timeline

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

  1. First posted2 May 2016 (estimated)
  2. Study start13 Jun 2016
  3. Primary completion14 Aug 2018
  4. Study completion11 Sep 2018

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
715 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02757768
Sponsor's protocol ID
178-MA-1008
Other IDs
2015-004036-36, 2015
Acronym
PLUS
Status last verified
Oct 2024
First submitted
15 Apr 2016
Last updated
12 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mirabegron and Tamsulosin Hydrochloride in people with Benign Prostatic Hyperplasia and Overactive Bladder, run by Astellas Pharma Global Development, Inc. at 79 sites in 9 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 11 inclusion and 37 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Canada, Italy, Germany, Spain and 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Oct 2019). 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 Micturitions Per Day (time frame: Baseline and Week 12). 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 NCT02757768.

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 12 Nov 2024.

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PLUS Clinical Trial NCT02757768 | AzTrials