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Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00399464
First received: November 13, 2006
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH.

The secondary objective is to assess the safety of SL77.0499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride.


Condition Intervention Phase
Prostatic Hyperplasia
 Drug: alfuzosin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of SL77.0499-10 10mg Once Daily in Comparison With Placebo and Tamsulosin Hydrochloride 0.2mg in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)

Secondary Outcome Measures:
  • Efficacy: Change in I-PSS total score from baseline to each visit
  • Change in Quality Of Life score from baseline to each visit
  • Change from baseline to endpoint of residual urine volume and urinary Peak Flow
  • Safety:Adverse events

Enrollment: 1177
Study Start Date: November 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:

  • Japanese;
  • Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months;
  • Suffering for at least 6 months from lower urinary tract symptoms related to BPH.

Exclusion Criteria:

  • Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment;
  • Inpatient;
  • Patients having participated in a clinical trial within the previous 6-month;
  • Patients previously treated with SL77.0499-10;
  • Patients whose I-PSS total score do not meet ≥ 13;
  • Patients whose urinary peak flow rate (PFR) do not meet 5.0-12.0mL/s for a voided volume of at least 150mL;
  • Patients whose residual urine are > 200mL;

The investigator will evaluate whether there are other reasons why a patient may not participate.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399464

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: NCT00399464     History of Changes
Other Study ID Numbers: EFC5791
Study First Received: November 13, 2006
Last Updated: October 1, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
Benign Prostatic Hyperplasia
Adrenergic alpha-Antagonists
alfuzosin

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Adrenergic alpha-Antagonists
Alfuzosin
Tamsulosin
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013