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NCT00038896 Clinical Trial

Study Evaluating Venlafaxine ER in Adults With Panic Disorder

Panic Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038896
Other study ID # 0600B5-353
Secondary ID
Status Completed
Phase Phase 3
First received June 5, 2002
Last updated August 13, 2009
Start date April 2001
Est. completion date December 2002

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 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.

Recruitment information / eligibility
Status Completed
Enrollment 343
Est. completion date December 2002
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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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