An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Atherosclerosis

Treatments: Procedure: Blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847782

CV198-001

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hypercholesterolemia
• Statin monotherapy

Exclusion criteria

• Significant acute or chronic illness
• Secondary causes of hypercholesterolemia

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Blood draw (Group 1)

Other group

Description:

Normocholesterolemic Subjects Normal Healthy Volunteers

Treatment:

Procedure: Blood draw

Blood draw (Group 2)

Other group

Description:

Hypercholesterolemic Subjects

Treatment:

Procedure: Blood draw

Blood draw (Group 3)

Other group

Description:

Hypercholesterolemic Subjects with Statin Treatment

Treatment:

Procedure: Blood draw