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Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00229528
First received: September 27, 2005
Last updated: September 19, 2008
Last verified: September 2008
History of Changes

September 27, 2005
September 19, 2008
March 2004
May 2006   (final data collection date for primary outcome measure)
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
Same as current
Complete list of historical versions of study NCT00229528 on ClinicalTrials.gov Archive Site
To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.
Same as current
Not Provided
Not Provided
 
Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease

COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Coronary Artery Disease
Drug: Paxil-CR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • normal volunteers (without heart disease)
  • patients with heart disease
  • between ages 18 & 65

Exclusion Criteria:

  • children less than 18 years
  • adults greater than 65 years
  • those who can not keep appointments
  • patients within 2 weeks of a coronary catheterization
  • patients within 6 months of unstable angina or myocardial infarction
  • individuals with allergies to paroxetine or similar medications
  • individuals having adverse events to paroxetine or similar medications
  • individuals with diagnosis of mania
  • individuals with a diagnosis of hypomania
  • individuals with a diagnosis of bipolar disorders
  • individuals with a diagnosis of depression
  • individuals with a diagnosis of panic disorders
  • individuals with a diagnosis of seizure disorders
  • individuals with a history of suicide attempts
  • individuals with a diagnosis of hyponatremia
  • individuals with active bleeding disorders
  • individuals with a diagnosis of narrow angle glaucoma
  • individuals with an estimated creatinine clearance of less that 30 ml/min
  • individuals taking potentially interacting medications
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00229528
1000774
Not Provided
Stephen Hamilton, University of Oklahoma Dept of Pharmacy
University of Oklahoma
GlaxoSmithKline
Principal Investigator: Stephen F. Hamilton, Pharm.D. The University of Oklahoma College of Pharmacy
University of Oklahoma
September 2008

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