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
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: 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
Lower Urinary Tract Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014