Study Evaluating Venlafaxine ER in Patients With Panic Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

September 4, 2002

Last Updated Date

August 13, 2009

Start Date ^ICMJE

November 2001

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00044772 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Panic Disorder

Intervention ^ICMJE

Drug: Venlafaxine ER

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

653

Completion Date

April 2003

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00044772

Responsible Party

Study ID Numbers ^ICMJE

0600B5-399

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP