Study Evaluating Venlafaxine ER in Patients With Panic Disorder
NCT00044772
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- Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1
- Have sufficient symptoms to require anxiolytic drug therapy
- Have a score ≥4 on the Clinical Global Impressions Scale (CGI) severity of illness item at screening and baseline
- Known hypersensitivity to venlafaxine (IR or ER), related compounds, or paroxetine
- 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)
- Clinically important abnormality on screening physical examination, vital signs,
electrocardiogram (ECG), laboratory tests or urine drug screen
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Venlafaxine ER in Patients With Panic Disorder | |||
Official Title ICMJE | A Double-blind, Placebo-controlled, Parallel-group Comparison of Venlafaxine Extended-release Capsules and Paroxetine in Outpatients With Panic Disorder | |||
Brief Summary | The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in comparison to those of placebo. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Panic Disorder | |||
Intervention ICMJE | Drug: Venlafaxine ER | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 653 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | April 2003 | |||
Actual Primary Completion Date | April 2003 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00044772 | |||
Other Study ID Numbers ICMJE | 0600B5-399 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |