FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000154-76-IT
Enrollment
512
Registered
2005-12-14
Start date
2005-03-16
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostatic hyperplasia MedDRA version: 6.1 Level: PT Classification code 10004446

Interventions

Product Name: BXL628 Product Code: BXL628 Pharmaceutical Form: Capsule, soft Current Sponsor code: BXL628 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 75-

Sponsors

BIOXELL SPA
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026