An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Procedure: Blood draw

• Registration Number: NCT00847782
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Study Start: 2009-03
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-04
• Last Update Posted: 2009-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Hypercholesterolemia
• Statin monotherapy

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Exclusion Criteria

• Significant acute or chronic illness
• Secondary causes of hypercholesterolemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood draw (Group 2)	Blood draw	Hypercholesterolemic Subjects
Blood draw (Group 1)	Blood draw	Normocholesterolemic Subjects Normal Healthy Volunteers
Blood draw (Group 3)	Blood draw	Hypercholesterolemic Subjects with Statin Treatment

Primary Outcome Measures

Name	Time	Method
Serum PCSK9 concentration	Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled

Secondary Outcome Measures

Name	Time	Method
Serum HDL cholesterol concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum TG concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum Apo B concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum LDL cholesterol concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Trial Locations

Locations (1)

Local Institution; 🇨🇦 Montreal, Quebec, Canada