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Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: blood draw (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

This is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U. S. marketed brand Effexor XR) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals).

Clinical Details

Official title: An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)

Secondary outcome: Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women subjects aged 18 years or older.

- Current outpatient treatment with extended-release venlafaxine HCl (U. S. marketed

brand Effexor XR®), within the US Food and Drug Administration (FDA)-approved dosage range for depression (37. 5 mg/day to 225 mg/day), for 8 weeks or less.

- Ability to have a blood draw within 4 to 12 hours of the most recent dose of Effexor

XR®. Exclusion Criteria:

- Determination by the investigator that a blood draw is contraindicated.

- Participation in an investigational study within the past 30 days where the study

medication is not known.

- Previous treatment with Effexor XR® or extended-release venlafaxine HCl (generic) in

the 6 months prior to current treatment regimen.

- Treatment with DVS SR within the last 30 days.

Locations and Contacts

Pfizer Investigational Site, Birmingham, Alabama 35216, United States

Pfizer Investigational Site, Tuscon, Arizona 85710, United States

Pfizer Investigational Site, Little Rock, Arkansas 72223, United States

Pfizer Investigational Site, National City, California 91950, United States

Pfizer Investigational Site, Ocean Side, California 92056, United States

Pfizer Investigational Site, Oceanside, California 92056, United States

Pfizer Investigational Site, Santa Ana, California 92701, United States

Pfizer Investigational Site, Temecula, California 92591, United States

Pfizer Investigational Site, Colorado Springs, Colorado 80909, United States

Pfizer Investigational Site, Denver, Colorado 80204, United States

Pfizer Investigational Site, Cromwell, Connecticut 06416, United States

Pfizer Investigational Site, Milford, Connecticut 06460, United States

Pfizer Investigational Site, Coral Gables, Florida 33134, United States

Pfizer Investigational Site, Lauderhill, Florida 33319, United States

Pfizer Investigational Site, West Palm Beach, Florida 33407, United States

Pfizer Investigational Site, West Palm Beach, Florida 33409, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Naperville, Illinois 60563, United States

Pfizer Investigational Site, Wichita, Kansas 67211, United States

Pfizer Investigational Site, Wichita, Kansas 67207, United States

Pfizer Investigational Site, Crestview Hills, Kentucky 41017, United States

Pfizer Investigational Site, Florence, Kentucky 41042, United States

Pfizer Investigational Site, Columbia, Maryland 21045, United States

Pfizer Investigational Site, Pittsfield, Massachusetts 01201, United States

Pfizer Investigational Site, Watertown, Massachusetts 02472, United States

Pfizer Investigational Site, Kalamazoo, Michigan 49009, United States

Pfizer Investigational Site, Stevensville, Michigan 49127, United States

Pfizer Investigational Site, Chesterfield, Missouri 63017, United States

Pfizer Investigational Site, Jefferson City, Missouri 65109, United States

Pfizer Investigational Site, Kalispell, Montana 59901, United States

Pfizer Investigational Site, Las Vegas, Nevada 89119, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87108, United States

Pfizer Investigational Site, Brooklyn, New York 11223, United States

Pfizer Investigational Site, Brooklyn, New York 11235, United States

Pfizer Investigational Site, Staten Island, New York 10312, United States

Pfizer Investigational Site, Charlotte, North Carolina 28209, United States

Pfizer Investigational Site, Wilmington, North Carolina 28401, United States

Pfizer Investigational Site, Bismarck, North Dakota 58051, United States

Pfizer Investigational Site, Fargo, North Dakota 58104, United States

Pfizer Investigational Site, Cincinnati, Ohio 45245, United States

Pfizer Investigational Site, Kettering, Ohio 45429, United States

Pfizer Investigational Site, Mason, Ohio 45040, United States

Pfizer Investigational Site, Norman, Oklahoma 73069, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 10213, United States

Pfizer Investigational Site, Bridgeville, Pennsylvania 15017, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19139, United States

Pfizer Investigational Site, Pottstown, Pennsylvania 19464, United States

Pfizer Investigational Site, Reading, Pennsylvania 19606, United States

Pfizer Investigational Site, Greenville, South Carolina 29615, United States

Pfizer Investigational Site, Mt. Pleasant, South Carolina 29464, United States

Pfizer Investigational Site, Memphis, Tennessee 38119, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Bellevue, Washington 98004, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2008
Last updated: January 5, 2011

Page last updated: August 23, 2015

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