Study Evaluating Venlafaxine ER in Adults With Panic Disorder

NCT00038896

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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

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


- 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)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Venlafaxine ER in Adults With Panic Disorder
Official Title  ICMJE A Double-blind, Placebo-controlled, Parallel-group, Flexible-dose Study of Venlafaxine Extended-release Capsules in Adult Outpatients With Panic Disorder
Brief 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.
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 * Liebowitz MR, Asnis G, Mangano R, Tzanis E. A double-blind, placebo-controlled, parallel-group, flexible-dose study of venlafaxine extended release capsules in adult outpatients with panic disorder. J Clin Psychiatry. 2009 Apr;70(4):550-61. Epub 2009 Apr 7.

*   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)
343
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
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 Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00038896
Other Study ID Numbers  ICMJE 0600B5-353
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 MonitorWyeth 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