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OpenTrials
Completed

NCT Number: NCT00637715

Once Daily Given Alfuzosin in the Treatment of BPH

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

Completed

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alfuzosin

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 18, 2008
Registry last updated
Apr 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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