An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

Atherosclerosis Clinical Trial

Official title:

An Experimental Medicine Study to Quantify PCSK9 Serum Concentrations and LDL Receptor Expression in Peripheral Blood Cells in Normal and Hypercholesterolemic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847782
• Other study ID #: CV198-001
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: November 4, 2009
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hypercholesterolemia

• Statin monotherapy

Exclusion Criteria:

• Significant acute or chronic illness

• Secondary causes of hypercholesterolemia

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Procedure:
• Blood draw
1 day

Locations

Country	Name	City	State
Canada	Local Institution	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum PCSK9 concentration		Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled	No
Secondary	Serum LDL cholesterol concentration		Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects	No
Secondary	Serum HDL cholesterol concentration		Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects	No
Secondary	Serum TG concentration		Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects	No
Secondary	Serum Apo B concentration		Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form