Study Evaluating Venlafaxine ER in Patients With Panic Disorder

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Venlafaxine ER

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic, Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00044772

First Posted

September 4, 2002

Last Updated

August 13, 2009

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00044772

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

November 2001 (undefined)

Primary Completion Date

April 2003 (Actual)

Study Completion Date

April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Panic Disorder

Keywords

Panic, Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

653 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Venlafaxine ER

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor, MD

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

Panic Disorder

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial