Study Evaluating Venlafaxine ER in Adults With Panic Disorder

August 13, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Double-blind, Placebo-controlled, Parallel-group, Flexible-dose Study of Venlafaxine Extended-release Capsules in Adult Outpatients With Panic Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

June 5, 2002

First Submitted That Met QC Criteria

June 6, 2002

First Posted (Estimate)

June 7, 2002

Study Record Updates

Last Update Posted (Estimate)

August 14, 2009

Last Update Submitted That Met QC Criteria

August 13, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0600B5-353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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