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NCT00637715 Clinical Trial

Once Daily Given Alfuzosin in the Treatment of BPH

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00637715
Other study ID # L_8758
Secondary ID
Status Completed
Phase Phase 4
First received March 11, 2008
Last updated April 1, 2008
Start date October 2003
Est. completion date December 2004

Study information
Verified date April 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Hungary: OGYI (Országos Gyógyszerészeti Intézet)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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.

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

Intervention

Drug:
• Alfuzosin

Locations
Country Name City State
Hungary Sanofi-Aventis Budapest

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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