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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

Page last updated: August 23, 2015

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