A randomized, double blind, double dummy, placebo controlled, parallel group study to determine the effect of BXL628 in monotherapy 75 mcg and 150 mcg and in combination 150 mcg with tamsulosin 0.4 mg in patients with benign prostatic hyperplasia BPH
- Conditions
- Benign prostatic hyperplasiaMedDRA version: 6.1Level: PTClassification code 10004446
- Registration Number
- EUCTR2005-000154-76-IT
- Lead Sponsor
- BIOXELL SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 512
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method