Trials / Completed
CompletedNCT01716104
Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (actual)
- Sponsor
- Materia Medica Holding · Industry
- Sex
- Male
- Age
- 45 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Afalaza | Safety and Efficacy |
| DRUG | Placebo | Safety and Efficacy |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2012-10-29
- Last updated
- 2018-11-28
- Results posted
- 2018-10-09
Locations
16 sites across 2 countries: Russia, Ukraine
Source: ClinicalTrials.gov record NCT01716104. Inclusion in this directory is not an endorsement.