CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 260 enrolled
Drug / intervention
Afalaza +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01716104
NCT01716104Phase 3Completed
CompareCT.gov

Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Materia Medica Holding·interventional·Posted Oct 29, 2012·Updated Nov 28, 2018

In Brief

A Phase 3 clinical trial evaluating Afalaza and Placebo for Benign Prostatic Hyperplasia. Completed, enrolled 260 participants across 16 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesRussia, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2012
Enrollment StartNov 1, 2012
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 13.7 years ago

Interventions

Afalazadrug

Safety and Efficacy

Placebodrug

Safety and Efficacy