Study Evaluating Venlafaxine ER in Patients With Panic Disorder
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Panic Disorder
Intervention: Venlafaxine ER (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, MD, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
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.
Clinical Details
Official title: A Double-blind, Placebo-controlled, Parallel-group Comparison of Venlafaxine Extended-release Capsules and Paroxetine in Outpatients With Panic Disorder
Study design: Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: November 2001
Last updated: August 13, 2009
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