Study Evaluating Venlafaxine ER in Adults With Panic Disorder

Phase 3

Completed

• Conditions: Panic Disorder

• Registration Number: NCT00038896
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-06
• Study First Posted: 2002-06-07
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-13
• Last Update Posted: 2009-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified