Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00347061
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date October 2, 2009
Study Start Date  ICMJE May 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
One year safety data of SL77.0499-10
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00347061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
One year efficacy data and plasma concentration of SL77.0499-10
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
Official Title  ICMJE 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.
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE Drug: afuzosin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2009)
148
Original Enrollment  ICMJE
 (submitted: June 30, 2006)
150
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347061
Other Study ID Numbers  ICMJE LTS5235
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP