Trials / Withdrawn
WithdrawnNCT01203371
Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Apsen Farmaceutica S.A. · Industry
- Sex
- Male
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.
Detailed description
Inclusion Criteria: Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR \> 150mL
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naftopidil | 0,25 mg (2weeks) and 0,50 mg (10 weeks) |
| DRUG | Tamsulosin | 0,4 mg/day |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2011-09-01
- Completion
- 2012-01-01
- First posted
- 2010-09-16
- Last updated
- 2023-02-08
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01203371. Inclusion in this directory is not an endorsement.