A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to Assess Efficacy and Safety of Dutasteride 0.5mg Once Daily in Chinese Patients With Benign Prostatic Hyperplasia (BPH), Followed by a 12-month Open-label Treatment Phase

GlaxoSmithKline1 site in 1 country253 target enrollmentOctober 2007

ConditionsBenign Prostatic Hyperplasia Prostatic Hyperplasia

InterventionsDutasteride 0.5mg capsule Dutasteride matched placebo

DrugsDutasteride 0.5mg capsule Dutasteride matched placebo

Overview

Phase: Phase 3
Intervention: Dutasteride 0.5mg capsule
Conditions: Benign Prostatic Hyperplasia
Sponsor: GlaxoSmithKline
Enrollment: 253
Locations: 1
Primary Endpoint: Percent Change From Baseline in the Prostate Volume at Month 6
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

March 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

A

dutasteride 0.5mg once daily orally

Intervention: Dutasteride 0.5mg capsule

B

Placebo matched once daily orally

Intervention: Dutasteride matched placebo

Outcomes

Primary Outcomes

Percent Change From Baseline in the Prostate Volume at Month 6

Time Frame: Baseline and Month 6

Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.

Secondary Outcomes

Percent Change From Baseline in the Prostate Volume at Month 3(Baseline and Month 3)
Change From Baseline in the Prostate Volume at Month 6(Baseline and Month 6)
Change From Baseline in the Prostate Volume at Month 3(Baseline and Month 3)
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6(Baseline and Month 6)
Percent Change From Baseline in the Serum DHT at Month 3(Baseline and Month 3)
Change From Baseline in the Serum DHT at Month 6(Baseline and Month 6)
Change From Baseline in the Serum DHT at Month 3(Baseline and Month 3)
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6(Baseline and Month 6)
Percent Change From Baseline in the AUA-SI Score at Month 3(Baseline and Month 3)
Change From Baseline in the AUA-SI Score at Month 6(Baseline and Month 6)
Change From Baseline in the AUA-SI Score at Month 3(Baseline and Month 3)
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6(Baseline and Month 6)
Percent Change From Baseline in Qmax at Month 3(Baseline and Month 3)
Change From Baseline in Qmax at Month 6(Baseline and Month 6)
Change From Baseline in Qmax at Month 3(Baseline and Month 3)