ALF-ONE : ALFuzosin ONcE Daily
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00280605 |
Recruitment Status :
Completed
First Posted : January 23, 2006
Last Update Posted : August 31, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostatic Hyperplasia | Drug: Alfuzosin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 200 participants |
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 |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | February 2006 |

- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280605
Study Director: | Benedict Blayney, MD | Sanofi |
ClinicalTrials.gov Identifier: | NCT00280605 |
Other Study ID Numbers: |
PM_L_0168 |
First Posted: | January 23, 2006 Key Record Dates |
Last Update Posted: | August 31, 2010 |
Last Verified: | August 2010 |
Prostatic Hyperplasia Hyperplasia Pathologic Processes Prostatic Diseases 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 |