ALF-ONE : ALFuzosin ONcE Daily

Prostatic Hyperplasia Clinical Trial

Official title:

Study of the Outcome of Patients With Lower Urinary Symptoms Suggestive of Benign Prostatic Hyperplasia and Treated With Alfuzosin 10 mg Once Daily for 3 Months in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280605
• Other study ID #: PM_L_0168
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2006
• Last updated: August 30, 2010
• Start date: August 2005
• Est. completion date: February 2006

Study information

• Verified date: August 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

Exclusion Criteria:

• Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months

• Patients previously not improved by an alpha 1-blocker treatment

• Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)

• Known hypersensitivity to alfuzosin

• History of postural hypotension or syncope

• Combination with other alpha 1-blockers

• Hepatic insufficiency

• Unstable angina pectoris

• Severe concomitant condition threatening life

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Alfuzosin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous adverse events
Primary	Blood pressure and heart rate measured in sitting position
Primary	International Prostate Symptom Score (IPSS) and quality of life index
Primary	DAN-PSS sexual function score
Primary	PSA levels measured at baseline
Primary	Maximum flow rate and residual urine