Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine
NCT ID: NCT00825019
Last Updated: 2009-03-25
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
306 participants
INTERVENTIONAL
2003-09-30
2004-12-31
Brief Summary
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Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
amibegron (SR58611A)
oral administration of 2x 700 mg/day in 12h intervals
2
placebo
oral administration in 12h intervals
3
paroxetine
paroxetine
oral administration of 20 mg/day
Interventions
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amibegron (SR58611A)
oral administration of 2x 700 mg/day in 12h intervals
placebo
oral administration in 12h intervals
paroxetine
oral administration of 20 mg/day
Eligibility Criteria
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Inclusion Criteria
* patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
* the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.
18 Years
65 Years
ALL
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 Administrative Office
Bridgewater, New Jersey, United States
Countries
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Other Identifiers
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EFC5379
Identifier Type: -
Identifier Source: org_study_id
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