- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347061
Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
October 1, 2009 updated by: Sanofi
A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.
Primary:
To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
Secondary:
- To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
- To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.
Study Overview
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography
- Suffering for at least 6 months from lower urinary tract symptoms related to BPH
- An I-PSS total score ≥ 13
- Out patient
Exclusion Criteria:
- Patients previously treated with SL77.0499-10.
- Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.
- Isolated bladder neck disease.
- Diagnosed carcinoma of the prostate.
- Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH.
- Patients having an indwelling catheter.
- A residual urine > 200mL.
- Patients with Moderate or sever hepatic insufficiency.
- Known hypersensitivity to alpha1-blockers.
- Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
- Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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One year safety data of SL77.0499-10
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Secondary Outcome Measures
Outcome Measure |
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One year efficacy data and plasma concentration of SL77.0499-10
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
June 30, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
October 2, 2009
Last Update Submitted That Met QC Criteria
October 1, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTS5235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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