Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia
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ClinicalTrials.gov Identifier: NCT00409357 |
Recruitment Status :
Completed
First Posted : December 8, 2006
Last Update Posted : October 2, 2009
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The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH.
Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Benign Prostatic Hyperplasia | Drug: SL77.0499-10 (alfuzosin hydrochloride) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 473 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of SL77.0499-10 Once Daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH) |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | August 2005 |

- The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.
- Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit.
- Safety: adverse events, vital signs, laboratory tests.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- suffering from LUTS related to BPH for at least 6 months;
- having an IPSS >13;
- having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL;
- having a residual urine volume < or = 200 mL.

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): NCT00409357
Japan | |
Sanofi-Aventis | |
Tokyo, Japan |
Study Director: | ICD CSD | Sanofi |
Responsible Party: | ICD Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00409357 |
Other Study ID Numbers: |
DRI5234 |
First Posted: | December 8, 2006 Key Record Dates |
Last Update Posted: | October 2, 2009 |
Last Verified: | October 2009 |
urinary tract |
Prostatic Hyperplasia Hyperplasia Lower Urinary Tract Symptoms Pathologic Processes Prostatic Diseases Urological Manifestations 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 |