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NCT00044772 Clinical Trial

Study Evaluating Venlafaxine ER in Patients With Panic Disorder

Panic Disorder Clinical Trial

Official title:
A Double-blind, Placebo-controlled, Parallel-group Comparison of Venlafaxine Extended-release Capsules and Paroxetine in Outpatients With Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00044772
Other study ID # 0600B5-399
Secondary ID
Status Completed
Phase Phase 3
First received September 4, 2002
Last updated August 13, 2009
Start date November 2001
Est. completion date April 2003

Study information
Verified date August 2009
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 653
Est. completion date April 2003
Est. primary completion date April 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Venlafaxine ER

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer
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