NCT00409357CompletedPhase 2
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)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 473
- Locations
- 1
- Primary Endpoint
- The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- 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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.
Secondary Outcomes
- 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.
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic EtiologyUrinary Bladder NeurogenicNCT00629720Sanofi29
Completed
Phase 3
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder DysfunctionNeurogenic Urinary BladderNCT00549939Sanofi172
Active, not recruiting
Phase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma ExacerbationsAsthmaNCT06052267Teva Branded Pharmaceutical Products R&D LLC2,772
Completed
Phase 2
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)Cardiovascular DiseasesHeart DiseasesNCT00059215Eli Lilly and Company905
Completed
Phase 2
Alfuzosin for Treating Acute Urinary RetentionAcute Urinary RetentionNCT00336921Sanofi156