Clinical Trial in Males With BPH (Enlarged Prostate)

Phase 3 Completed 1522 enrolled Sanofi

RandomizedParallel-groupDouble-blindPrevention

Summary

A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. * Free study-related medical care provided.

Timeline

Start: 2001-05
Primary completion: —
Completion: 2005-03

Outcome

Missed primary endpoint

paper Alfuzosin did not reduce the risk of AUR (alfuzosin 2.1% vs placebo 1.8%, P = 0.82) PMID 16536764 ↗

paper but does not reduce the primary occurrence of AUR. PMID 16536764 ↗

Publications

Results Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41. doi: 10.1111/j.1464-410X.2006.06110.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alfuzosin	Small molecule	10 mg	—