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NCT01203371 Clinical Trial

Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

Hyperplasia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01203371
Other study ID # APS 001/2010
Secondary ID BRA10APS001
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date January 1, 2011
Est. completion date January 1, 2012

Study information
Verified date February 2023
Source Apsen Farmaceutica S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 1, 2012
Est. primary completion date September 1, 2011
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria: - Men = 50 years - Signs and symptoms of BPH - IPSS of = 10 - Prostate volume of = 20 mL - PVR > 150 mL Exclusion Criteria: - History of allergy to a AR antagonists - Treatment with antiandrogen drugs - Drugs with anticholinergic activity - Significant history of orthostatic hypotension - Concomitant neurological diseases - Known or suspected neurogenic bladder dysfunction - Carcinoma of the prostate or bladder - Previous surgery for BPH or bladder neck obstruction - History of recurrent UTI - Concomitant active UTI

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Naftopidil
0,25 mg (2weeks) and 0,50 mg (10 weeks)
• Tamsulosin
0,4 mg/day

Locations
Country Name City State
Brazil Hospital das Clínicas da Faculdade de Medicina da USP São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Apsen Farmaceutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary International Prostate Symptom Score 2, 4, 8 and 12 weeks
Secondary Adverse Effect 2, 4, 8 and 12 weeks
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