Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-30 @ 7:50 AM
Study NCT ID:
NCT01716104
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Sponsor:
Materia Medica Holding
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: