Study Evaluating Venlafaxine ER in Patients With Panic Disorder

NCT00044772

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Panic Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Venlafaxine ER in Patients With Panic Disorder
Official Title  ICMJE A Double-blind, Placebo-controlled, Parallel-group Comparison of Venlafaxine Extended-release Capsules and Paroxetine in Outpatients With Panic Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE Drug: Venlafaxine ER
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2009)
653
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2003
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00044772
Other Study ID Numbers  ICMJE 0600B5-399
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP