Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
NCT ID: NCT00347061
Last Updated: 2009-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2006-05-31
2007-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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afuzosin
Eligibility Criteria
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Inclusion Criteria
* Suffering for at least 6 months from lower urinary tract symptoms related to BPH
* An I-PSS total score ≥ 13
* Out patient
Exclusion Criteria
* 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.
50 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Tokyo, , Japan
Countries
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Other Identifiers
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LTS5235
Identifier Type: -
Identifier Source: org_study_id
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