Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Apsen Farmaceutica S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Apsen Farmaceutica S.A.
ClinicalTrials.gov Identifier:
NCT01203371
First received: September 15, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hyperplasia
Drug: Naftopidil
Drug: Tamsulosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Apsen Farmaceutica S.A.:

Primary Outcome Measures:
  • International Prostate Symptom Score [ Time Frame: 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Effect [ Time Frame: 2, 4, 8 and 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naftopidil
0,25 mg (2 weeks) and 0,50 mg (10 weeks)
Drug: Naftopidil
0,25 mg (2weeks) and 0,50 mg (10 weeks)
Other Name: NAFTOPIDIL
Active Comparator: Tamsusolin
0,4 mg/day
Drug: Tamsulosin
0,4 mg/day
Other Name: SECOTEX

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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203371

Contacts
Contact: Fabiane F Machado 55 11 5644 8211 fabiane.machado@apsen.com.br
Contact: Cristiane P Lima 55 11 5644 8200 ext 8269 cristiane.lima@apsen.com.br

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP Not yet recruiting
São Paulo, Brazil, 05403-010
Contact: Geraldo C Freire, PhD    55 11 3069-8082      
Contact: Camila C Marin    55 11 3069-8082    camila.marin@ig.com.br   
Principal Investigator: Geraldo C Freire, PhD         
Sponsors and Collaborators
Apsen Farmaceutica S.A.
  More Information

No publications provided

Responsible Party: Apsen Farmacêutica S.A., Apsen
ClinicalTrials.gov Identifier: NCT01203371     History of Changes
Other Study ID Numbers: APS 001/2010, BRA10APS001
Study First Received: September 15, 2010
Last Updated: September 15, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Apsen Farmaceutica S.A.:
naftopidil
symptoms of lower urinary tract
benign prostate hyperplasia
LUTS
Benign Prostate Hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Naftopidil
Tamsulosin
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Platelet Aggregation Inhibitors
Hematologic Agents
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on July 22, 2014