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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00481325 |
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder
Condition | Intervention | Phase |
---|---|---|
Generalized Anxiety Disorder |
Drug: pexacerfont Drug: escitalopram Drug: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder |
Enrollment: | 260 |
Study Start Date: | July 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A1: Experimental |
Drug: pexacerfont
Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
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A2: Active Comparator |
Drug: escitalopram
Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
|
A3: Placebo Comparator |
Drug: placebo
Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CN148-015 |
Study First Received: | May 31, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00481325 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Cholinergic Antagonists Psychotropic Drugs Cholinergic Agents Serotonin Uptake Inhibitors Citalopram Serotonin |
Muscarinic Antagonists Anxiety Disorders Mental Disorders Peripheral Nervous System Agents Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents |
Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Pathologic Processes Mental Disorders Therapeutic Uses |
Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Disease Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Anxiety Disorders Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |