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Once Daily Given Alfuzosin in the Treatment of BPH

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00637715
First received: March 11, 2008
Last updated: April 1, 2008
Last verified: April 2008
History of Changes
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia
 Drug: Alfuzosin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) [ Time Frame: 6 months ]

Enrollment: 60
Study Start Date: October 2003
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637715

Locations
Hungary
Sanofi-Aventis
Budapest, Hungary
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Laszlo Eros Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637715     History of Changes
Other Study ID Numbers: L_8758
Study First Received: March 11, 2008
Last Updated: April 1, 2008
Health Authority: Hungary: OGYI (Országos Gyógyszerészeti Intézet)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013