Back to resultsStudy Evaluating Venlafaxine ER in Adults With Panic Disorder
Primary Purpose
Panic Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Venlafaxine ER
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring Panic, Disorder
Eligibility Criteria
Inclusion Criteria: A male or female outpatient Be at least 18 years of age and legal age of consent Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1 Exclusion Criteria: Treatment with venlafaxine (IR or ER) within 6 months of study day 1 Known hypersensitivity to venlafaxine (IR or ER) or related compounds History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma [except basal cell epithelioma], uncontrolled hypertension)
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00038896
First Posted
June 5, 2002
Last Updated
August 13, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00038896
Brief Title
Study Evaluating Venlafaxine ER in Adults With Panic Disorder
Official Title
A Double-blind, Placebo-controlled, Parallel-group, Flexible-dose Study of Venlafaxine Extended-release Capsules in Adult Outpatients With Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic, Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
343 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Venlafaxine ER
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A male or female outpatient
Be at least 18 years of age and legal age of consent
Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1
Exclusion Criteria:
Treatment with venlafaxine (IR or ER) within 6 months of study day 1
Known hypersensitivity to venlafaxine (IR or ER) or related compounds
History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma [except basal cell epithelioma], uncontrolled hypertension)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19358784
Citation
Liebowitz MR, Asnis G, Mangano R, Tzanis E. A double-blind, placebo-controlled, parallel-group, flexible-dose study of venlafaxine extended release capsules in adult outpatients with panic disorder. J Clin Psychiatry. 2009 Apr;70(4):550-61. doi: 10.4088/jcp.08m04238. Epub 2009 Apr 7.
Results Reference
derived
Learn more about this trial
Study Evaluating Venlafaxine ER in Adults With Panic Disorder
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