ALF-ONE : ALFuzosin ONcE Daily

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00280605
• Collaborator: (none)
• Enrollment: 200
• Duration (Months): 6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: Alfuzosin	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. Spontaneous adverse events []

2. Blood pressure and heart rate measured in sitting position []

3. International Prostate Symptom Score (IPSS) and quality of life index []

4. DAN-PSS sexual function score []

5. PSA levels measured at baseline []

6. Maximum flow rate and residual urine []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Benedict Blayney, MD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00280605
• Other Study ID Numbers: PM_L_0168
• First Posted: Jan 23, 2006
• Last Update Posted: Aug 31, 2010
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Alfuzosin

Study Results

No Results Posted as of Aug 31, 2010