Status:
COMPLETED
Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia
Lead Sponsor:
Sanofi
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE3
Brief Summary
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 te...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
1177 Patients enrolled
Trial Details
Trial ID
NCT00399464
Start Date
November 1 2006
End Date
October 1 2007
Last Update
October 2 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan