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PERmixon® in LUTS Evaluation Study (PERLES)

NCT02121613 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 833

Last updated 2016-09-02

No results posted yet for this study

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

  • Benign Prostatic Hyperplasia (BPH)

Interventions

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.

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Karim Keddad, MD · Pierre Fabre Medicament

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121613 on ClinicalTrials.gov