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OpenTrials
Completed

NCT Number: NCT00280605

ALF-ONE : ALFuzosin ONcE Daily

The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

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Key information

Conditions

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

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

Exclusion criteria

  • Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months
  • Patients previously not improved by an alpha 1-blocker treatment
  • Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)
  • Known hypersensitivity to alfuzosin
  • History of postural hypotension or syncope
  • Combination with other alpha 1-blockers
  • Hepatic insufficiency
  • Unstable angina pectoris
  • Severe concomitant condition threatening life

Treatment and study plan

Alfuzosin

Drug

Primary outcomes

  1. Spontaneous adverse events

  2. Blood pressure and heart rate measured in sitting position

  3. International Prostate Symptom Score (IPSS) and quality of life index

  4. DAN-PSS sexual function score

  5. PSA levels measured at baseline

  6. Maximum flow rate and residual urine

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Study of the Outcome of Patients With Lower Urinary Symptoms Suggestive of Benign Prostatic Hyperplasia and Treated With Alfuzosin 10 mg Once Daily for 3 Months in China

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 23, 2006
Registry last updated
Aug 31, 2010

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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