Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Summary

The purpose of this study is: * To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression. * To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.

Timeline

Start

2012-11

Primary completion

2016-11

Completion

2016-11

Outcome

Met primary endpoint

registry analysis (superiority test); Afalaza vs Placebo; p = 0.0005; Mixed Models Analysis NCT01716104 ↗

Publications

• Pushkar D, Vinarov A, Spivak L, Kolontarev K, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: a multicenter, double-blind, placebo-controlled, randomized clinical trial. Cent European J Urol. 2018;71(4):427-435. doi: 10.5173/ceju.2018.1803. Epub 2018 Dec 27.

Drugs

Indications