Study to evaluate the efficacy and safety of use mirabegron in men who already take tamsulosin because they have enlarged prostate and an overactive bladder
- Conditions
- Over active bladder (OAB) in men with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)MedDRA version: 19.0 Level: PT Classification code 10046543 Term: Urinary incontinence System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2015-004036-36-GB
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 715
1. Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)-approved written
Informed Consent and privacy language as per national regulations (e.g., HIPAA
Authorization for US sites) must be obtained from the subject or legally authorized
representative prior to any study-related procedures (including withdrawal of prohibited
medication, if applicable).
2. Men =40 years of age with history of OAB symptoms (urinary frequency and urgency
with or without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at least 2 months to treat LUTS due to BPH.
3. Subject has symptoms of OAB (frequency of =8 micturitions per day and urgency episodes of =2 per day) for =3 months prior to Screening.
4. Subject has an IPSS score =8.
5. Subject has Prostate-Specific Antigen (PSA) < 4 ng/mL.
6. Subject is willing and able to complete the 3-day diary (including urine volumes, vital
sign measurements), and Quality of Life questionnaires.
7. Subject and their spouses/partners who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or 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.
8. 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:
9. Subject continues to meet all inclusion criteria of Visit 1 (Screening).
10. Subject must experience an average of 8 or more micturitions per day over the 3-day
diary period.
11. Subject must experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-day diary period.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 439
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 878
1. Subject has PVR >200 mL.
2. Subject has Qmax <5.0 mL/second with a min voided volume of 125 mL.
3. Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
4. Subject has evidence of UTI.
5. Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
6. Subject has diabetic neuropathy.
7. Previous open, robotic or minimally invasive prostate surgery (including transurethral
procedures). Planned (scheduled) pelvic or prostate surgery planned during the study
period.
8. Planned (scheduled) cataract surgery during the study period.
9. Subject with significant stress incontinence as determined by the Investigator.
10. Subject with clinically significant bladder outlet obstruction as determined by the
Investigator.
11. Subject has an indwelling catheter or practices intermittent self-catheterization.
12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the last 12 months.
13. 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 as the distal ascending colon, the full transverse
colon and proximal portion of the descending colon are in the abdomen).
14. Subject has received intravesical injection in the past 12 months with botulinum toxin,
resiniferatoxin, or capsaicin.
15. Subject has ever received electro-stimulation therapy for OAB (e.g. sacral nerve
stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
16. Subject began or has changed a bladder training program or pelvic floor exercises less
than 30 days prior to Screening.
17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
19. Subject has severe renal impairment defined as estimated creatinine clearance less than
29 mL/min/1.73m2 as determined by central laboratory calculation of eGFR. A subject
with End Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for
the study.
20. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg.
21. Subject has baseline resting pulse rate <60 BPM or >90 BPM.
22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2) electrocardiogram (ECG) defined as QTcF >450 msec.
23. Subject has any clinically significant ECG abnormality, as determined by the Investigator.
24. Subject has AST or ALT >2x upper limit of normal (ULN), or ?-GT >3x ULN and considered clinically significant by
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the efficacy of mirabegron versus placebo in men with OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.;Secondary Objective: To assess safety and tolerability of mirabegron versus placebo in men with OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.;Primary end point(s): Change from Baseline (Visit 2) to Week 12/ End of Treatment (Visit 5) in mean number of micturitions per day based on a 3-day diary.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method