Study Evaluating Venlafaxine ER in Adults With Panic Disorder

Wyeth

Status and phase: Completed; Phase 3

Conditions: Panic Disorder

Treatments: Drug: Venlafaxine ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038896

0600B5-353

Details and patient eligibility

About

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.

Enrollment: 343 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)