Last updated on April 2018

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)


Brief description of study

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).

Detailed Study Description

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). Approximately 7 days prior to Visit 2 subjects will receive a phone call reminding them about the diary and to answer any questions.

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. Those subjects randomized to mirabegron will start at 25 mg and will increase to 50 mg after 4 weeks. Those subjects randomized to placebo will start blinded product matched to the mirabegron 25 mg tablet and will increase to blinded product matched to 50 mirabegron after 4 weeks. Once a subject has increased dose, the subject will remain on that dose for the remainder of the study unless for safety reasons is required to discontinue study drug.

A training diary will be completed in the first 2 weeks of the tamsulosin hydrochloride run-in period. During this evaluation period at least one telephone contact will take place with the subject. Diaries will be 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 will contact the subject approximately 7 days prior to the scheduled visit to remind the subject 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), subjects will complete a 3-day diary, using the ePRO device in which the subject will record micturition frequency, urgency (PPIUS), incontinence and volume voided. In addition, the diary will capture morning and evening blood pressure and pulse rate measurements via Home Blood Pressure Monitoring (HBPM). At Visit 1, International Prostate Symptom Score (IPSS) will be completed. At Visits 2, 3, 4, and 5, subjects will complete the IPSS, EQ-5D-5L, OAB-q, PPBC, and TS-VAS. Maximum urinary flow (Qmax) will be measured at Visit 1 (Screening/tamsulosin hydrochloride run-in) and Visit 5 (Week 12/End of Treatment). Post-void residual volume (PVR) will be 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) will be conducted 4-weeks after End of Treatment (Visit 5). Total study participation is approximately 20 weeks.

Clinical Study Identifier: NCT02757768

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Astellas Pharma Global Development

Site US01044
Goodyear, AZ United States
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