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NCT00944866 Clinical Trial

Effects of Cox-II Inhibitor on Biochemical Markers in Cardiovascular-related Adverse Effects

Arthritis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00944866
Other study ID # C07146
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 22, 2009
Last updated July 22, 2009
Start date March 2008
Est. completion date February 2010

Study information
Verified date July 2009
Source National Chung Hsing University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

The selective cyclooxygenase-2 (COX-2) inhibitors have been associated with increased cardiovascular risk. The goal of the present study is to investigate the impacts of COX-2 inhibitors on biochemical indices in cardiovascular disease. As the reviewer suggested, the investigators propose to study the effects of Cox-II inhibitor using experimentally induced hyperlipidemic rats. Plasma total cholesterol, LDL and triglyceride concentrations will be determined before and after animals treated with cyclooxygenase-2 (COX-2) inhibitors. Biochemical markers related to cardiovascular events including prostaglandin I2, thromboxaneA2 and others will also be investigated. The investigators will also investigate these biochemical markers in patients taking Celecoxib and NSAIDs. The investigators hope these studies will reveal clinically useful biochemical markers for cardiovascular events in patients taking Cox-II inhibitor.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male/female age >18

- Clinical diagnosed of arthritis

Exclusion Criteria:

- Must not be pregnant/breastfeeding

- Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Chung Hsing University
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