Clinical Trial: Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride (0.5mg) and Tamsulosin (0.2mg) With Tamsulosin (0.2mg) Monotherapy, Admini

Brief Summary: This is a multicentre, randomised, double-blind, parallel group study in Asian subjects. The aim of the study is to investigate whether combination therapy with dutasteride and tamsulosin is more effective than tamsulosin monotherapy for the improvement of symptoms and health outcomes in an at risk population of benign prostatic hyperplasia (BPH) clinical progression including older men (>=50 years), with moderate-severe symptoms of BPH, enlarged prostates (>=30 cubicentimeter [cc]) and prostate specific antigen (PSA) >= 1.5 nanograms per milliliter (ng/mL). Each subject who met the eligibility criteria at screening will enter a four-week single-blind, placebo run-in period following which each subject will be randomised into a 2 year double-blind treatment phase. The total study duration for each subject will be up to 110 weeks.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change From Baseline in the International Prostate Symptom Score (IPSS) at Year 2 [ Time Frame: Baseline to Year 2 (Week 104) ]

The IPSS is a 7-item questionnaire that measures urinary symptoms, but with an additional, independent eighth question on quality of life. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. The first 7 items has a 6-point response scale (0=none/never to 5=almost always/5 or more times) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). The last item assesses quality of life reported as a Quality of Life assessment index.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage change from Baseline in Prostate Volume [ Time Frame: Baseline to Year 2 (Week 104) ]
    Prostate volume was measured by transrectal ultrasound (TRUS). The prostate volume will be calculated using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters).
  • Proportion of subjects with IPSS improvement of >=2 points and >=3 points from baseline and, separately, >=25% improvement from Baseline [ Time Frame: Baseline to Year 2 (Week 104) ]
  • Change from Baseline in maximum urinary flow rate (Qmax) [ Time Frame: Baseline to Year 2 (Week 104) ]
    Maximum urinary flow rate will be measured using an uroflow meter.
  • Proportion of subjects with Qmax improvement of >=3 milliliter per second (mL/sec) and, separately, >=30% improvement from baseline [ Time Frame: Baseline to Year 2 (Week 104) ]
  • Time to event/ proportion of subjects with acute urinary retention (AUR) or BPH related prostatic surgery [ Time Frame: Up to Year 2 (Week 104) ]
    Time to first AUR or BPH-related surgical intervention will be defined as the number of days from date of first dose of randomized study drug to date of the first event (earliest occurring of either AUR or BPH-related surgery) for each subject.
  • Time to event/proportion of subjects with AUR [ Time Frame: Up to Year 2 (Week 104) ]
    Time to first AUR -related surgical intervention will be defined as the number of days from date of first dose of randomized study drug to date of the first event (earliest occurring of either AUR related surgery) for each subject.
  • Time to event/proportion of subjects undergoing BPH related prostatic surgery [ Time Frame: Up to Year 2 (Week 104) ]
    Time to first BPH -related surgical intervention will be defined as the number of days from date of first dose of randomized study drug to date of the first event (earliest occurring of either BPH related surgery) for each subject.


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: January 23, 2014
Date Started: February 10, 2014
Date Completion:
Last Updated: April 4, 2017
Last Verified: April 2017