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Once Daily Given Alfuzosin in the Treatment of BPH

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ClinicalTrials.gov Identifier: NCT00637715
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : April 3, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : October 2003
Actual Study Completion Date : December 2004

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Arms and Interventions
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Outcome Measures
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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) [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637715


Locations
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Hungary
Sanofi-Aventis
Budapest, Hungary
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Laszlo Eros Sanofi
More Information
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Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637715     History of Changes
Other Study ID Numbers: L_8758
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: April 2008

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