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ALF-ONE : ALFuzosin ONcE Daily
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00280605
First received: January 20, 2006
Last updated: August 30, 2010
Last verified: August 2010
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Prostatic Hyperplasia | Drug: Alfuzosin | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Spontaneous adverse events
- Blood pressure and heart rate measured in sitting position
- International Prostate Symptom Score (IPSS) and quality of life index
- DAN-PSS sexual function score
- PSA levels measured at baseline
- Maximum flow rate and residual urine
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2005 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280605
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280605
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Benedict Blayney, MD | Sanofi |
More Information
| ClinicalTrials.gov Identifier: | NCT00280605 History of Changes |
| Other Study ID Numbers: |
PM_L_0168 |
| Study First Received: | January 20, 2006 |
| Last Updated: | August 30, 2010 |
Additional relevant MeSH terms:
|
Hyperplasia Prostatic 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 |
ClinicalTrials.gov processed this record on September 21, 2017