NCT00044772

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
653

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

August 14, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

September 4, 2002

Last Update Submit

August 13, 2009

Conditions

Panic Disorder

Keywords

PanicDisorder

Interventions

Venlafaxine ERDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Panic DisorderDisease

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2002

First Posted

September 6, 2002

Study Start

November 1, 2001

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

August 14, 2009

Record last verified: 2009-08