Effect of Paroxetine on COAT-Platelet Production in Norma... | NCT00229528

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

NCT00229528

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Sep 22, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Paxil-CR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Sep 27, 2005

First Submission Date that Met QC Criteria

Sep 27, 2005

First Posted Date

Sep 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2008

Last Update Posted Date

Sep 22, 2008Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Paxil-CR	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.

Secondary Outcomes

Measure	Description	Time Frame
To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen F. Hamilton, Pharm.D.	The University of Oklahoma College of Pharmacy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Oklahoma Health Sciences Center		Oklahoma City	Oklahoma	73190	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017374	Paroxetine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided