Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00347061
First received: June 30, 2006
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

Primary:

To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.

Secondary:

  • To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
  • To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.

Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: afuzosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • One year safety data of SL77.0499-10

Secondary Outcome Measures:
  • One year efficacy data and plasma concentration of SL77.0499-10

Enrollment: 148
Study Start Date: May 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography
  • Suffering for at least 6 months from lower urinary tract symptoms related to BPH
  • An I-PSS total score ≥ 13
  • Out patient

Exclusion Criteria:

  • Patients previously treated with SL77.0499-10.
  • Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.
  • Isolated bladder neck disease.
  • Diagnosed carcinoma of the prostate.
  • Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH.
  • Patients having an indwelling catheter.
  • A residual urine > 200mL.
  • Patients with Moderate or sever hepatic insufficiency.
  • Known hypersensitivity to alpha1-blockers.
  • Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
  • Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347061

Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00347061     History of Changes
Other Study ID Numbers: LTS5235
Study First Received: June 30, 2006
Last Updated: October 1, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
Benign Prostatic Hyperplasiam
Adrenergic alpha-antagonist

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014