Trials / Completed
CompletedNCT02121613
PERmixon® in LUTS Evaluation Study (PERLES)
PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 833 (actual)
- Sponsor
- Pierre Fabre Medicament · Industry
- Sex
- Male
- Age
- 45 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Permixon® 160 mg | Oral administration - 160 mg twice daily. |
| DRUG | Tamsulosine LP | Oral administration - 0.4 mg daily. |
| DRUG | Placebo matching Permixon® 160 mg | Oral administration - twice daily. |
| DRUG | Placebo matching Tamsulosine LP | Oral administration - daily. |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2014-04-23
- Last updated
- 2016-09-02
Locations
58 sites across 5 countries: Czechia, France, Germany, Italy, Spain
Source: ClinicalTrials.gov record NCT02121613. Inclusion in this directory is not an endorsement.