Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia; Prostatic Hyperplasia
• Interventions: Drug: Dutasteride 0.5mg capsule; Drug: Dutasteride matched placebo

• Registration Number: NCT00527605
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Study Start: 2007-10
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-02-22
• Results First Submitted QC: 2010-02-22
• Results First Posted: 2010-03-11
• Status Verified: 2011-05
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 253

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Dutasteride 0.5mg capsule	dutasteride 0.5mg once daily orally
B	Dutasteride matched placebo	Placebo matched once daily orally

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in the Prostate Volume at Month 6	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 Outcome Measures

Name	Time	Method
Percent Change From Baseline in the Prostate Volume at Month 3	Baseline and Month 3	Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.
Change From Baseline in the Prostate Volume at Month 6	Baseline and Month 6	Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.
Change From Baseline in the Prostate Volume at Month 3	Baseline and Month 3	Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6	Baseline and Month 6	Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.
Percent Change From Baseline in the Serum DHT at Month 3	Baseline and Month 3	Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.
Change From Baseline in the Serum DHT at Month 6	Baseline and Month 6	Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.
Change From Baseline in the Serum DHT at Month 3	Baseline and Month 3	Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.
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 is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Percent Change From Baseline in the AUA-SI Score at Month 3	Baseline and Month 3	Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Change From Baseline in the AUA-SI Score at Month 6	Baseline and Month 6	Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Change From Baseline in the AUA-SI Score at Month 3	Baseline and Month 3	Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6	Baseline and Month 6	Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.
Percent Change From Baseline in Qmax at Month 3	Baseline and Month 3	Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.
Change From Baseline in Qmax at Month 6	Baseline and Month 6	Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.
Change From Baseline in Qmax at Month 3	Baseline and Month 3	Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Tianjin, China