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). NCT02757768, 178-MA-1008.

  • STATUS
    Recruiting
Updated on 2 September 2021
mirabegron
incontinence
lower urinary tract symptoms
tamsulosin

Summary

The purpose of the study is 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).

At Screening (Visit 1), subjects will enter 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, subjects will complete a 3-day diary just prior to Baseline (Visit 2). 

If subjects meet all entry criteria at the end of the tamsulosin hydrochloride run-in period, subjects will be 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.

Description

For more information contact Cheryl Zinar, Director of Clinical Research, Urologic Consultants of Southeastern PA, 610-667-0458, Czinar@ucsepa.com.

Details
Condition Overactive Bladder, Benign Prostatic Hyperplasia (Enlarged Prostate)
Clinical Study IdentifierTX196746
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Symptoms of OAB (urinary frequency and urgency with or without incontinence) for ≥3 months prior to Screening
International Prostate Symptom Score (IPSS) score ≥8
Prostate-Specific Antigen (PSA) <4 ng/mL
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
Agrees not to participate in another interventional study while on treatment
Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day
diary
Must experience an average of 8 or more micturitions per day over the 3-day diary period
Must experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-diary period

Exclusion Criteria

Post-void residual volume (PVR) >200 mL
Maximum urinary flow (Qmax) <5.0 mL/second with a minimum voided volume of 125 mL
Hematuria >3 rbc/hpf that has not been fully evaluated
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)
Neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson's, etc.)
Diabetic neuropathy
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
Significant stress incontinence
Clinically significant bladder outlet obstruction
Indwelling catheter or practices intermittent self-catheterization
or more episodes of recurrent urinary tract infection within the last 12 months
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)
Intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin
Eelectro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS])
Bladder training program or pelvic floor exercises less than 30 days prior to Screening
Postural hypotension or syncope or postural orthostatic tachycardia
Moderate or severe hepatic impairment defined as Child-Pugh Class B or C
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
Severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg
Baseline resting pulse rate <60 BPM or >90 BPM
Evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2) electrocardiogram (ECG) defined as QTcF >450 msec
Clinically significant ECG abnormality
AST or ALT >2x upper limit of normal (ULN), or γ-GT >3x ULN and considered clinically significant
Hypersensitivity to any components of mirabegron, tamsulosin hydrochloride, or any of the inactive ingredients
History of angioedema
Clinical significant condition which makes the subject unsuitable for study participation
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
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
Ongoing alcohol and/or drug abuse
Prohibited medication use within 30 days prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6)
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)
Participation in an interventional trial within 30 days prior to Screening (Visit 1)
Previously received mirabegron in the 6 months prior to Screening (Visit 1)
Exclusion Criteria assessed at Visit 2 (Baseline)
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
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