PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (PERLES)

NCT02121613 Phase 4 COMPLETED

The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.

Details

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 4
Status	COMPLETED
Enrolment	833
Start date	2014-04
Completion	2016-06

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

• Permixon® 160 mg
• Tamsulosine LP
• Placebo matching Permixon® 160 mg
• Placebo matching Tamsulosine LP

Primary outcomes

• International Prostate Symptom Score (I-PSS score) change — Day 180
  I-PSS score change from baseline to D180

Countries

Czechia, France, Germany, Italy, Spain