Once Daily Given Alfuzosin in the Treatment of BPH

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00637715
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms
• Study Start Date: Oct 1, 2003
• Actual Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH) [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present

Exclusion Criteria:

• Necessity of surgical intervention immediately or within 12 months because of BPH

• The patient has earlier /within 6 months/ obtained treatment because of BPH

• The patient did not improve on earlier alpha-1 blocker treatment

• Known hypersensitivity to alfuzosin

• Orthostatic hypotension in the history

• Concomitant application with another alpha-1 blocker

• Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/

• Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/

• Intestinal obstruction /because of the castor oil content of the drug/

• Tumorous disease

• Severe, life threatening state

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Budapest		Hungary

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Laszlo Eros, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00637715
• Other Study ID Numbers: L_8758
• First Posted: Mar 18, 2008
• Last Update Posted: Apr 3, 2008
• Last Verified: Apr 1, 2008

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

Study Results

No Results Posted as of Apr 3, 2008