Conditions: Benign Prostatic Hyperplasia Prostatic Hyperplasia
Keywords: placebo control Chinese Dutasteride Randomized Benign Prostatic Hyperplasia Double blind
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 253
Healthy volunteers: no

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:

Arms:
arm 1: dutasteride 0.5mg once daily orally arm 2: Placebo matched once daily orally

Interventions: intervention 1: Dutasteride 0.5mg capsule intervention 2: Dutasteride matched placebo
Intervention descriptions: intervention 1: Dutasteride 0.5mg once daily orally intervention 2: Dutasteride matched placebo once daily orally

Protocol document: