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

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Study Evaluating Venlafaxine ER in Patients With Panic Disorder

This study is ongoing, but not recruiting participants.

Study NCT00044772. Last updated on May 18, 2006. Information provided by Wyeth

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Study Evaluating Venlafaxine ER in Patients With Panic Disorder

Official Title ^†

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 ^†

Interventional

Study Design ^†

Treatment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Panic Disorder

Intervention ^†

Drug: Venlafaxine ER

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00044772

Organization ID

0600B5-399

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

May 2006

First Received Date ^†

September 4, 2002

Last Updated Date

May 18, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.