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An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Blood draw

About this trial

This is an interventional screening trial for Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Hypercholesterolemia
Statin monotherapy

Exclusion Criteria:

Significant acute or chronic illness
Secondary causes of hypercholesterolemia

Sites / Locations

Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Blood draw (Group 1)

Blood draw (Group 2)

Blood draw (Group 3)

Arm Description

Normocholesterolemic Subjects Normal Healthy Volunteers

Hypercholesterolemic Subjects

Hypercholesterolemic Subjects with Statin Treatment

Outcomes

Primary Outcome Measures

Serum PCSK9 concentration

Secondary Outcome Measures

Serum LDL cholesterol concentration

Serum HDL cholesterol concentration

Serum TG concentration

Serum Apo B concentration

Full Information

NCT ID

NCT00847782

First Posted

February 6, 2009

Last Updated

November 4, 2009

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00847782

Brief Title

An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blood draw (Group 1)

Arm Type

Other

Arm Description

Normocholesterolemic Subjects Normal Healthy Volunteers

Arm Title

Blood draw (Group 2)

Arm Type

Other

Arm Description

Hypercholesterolemic Subjects

Arm Title

Blood draw (Group 3)

Arm Type

Other

Arm Description

Hypercholesterolemic Subjects with Statin Treatment

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

1 day

Primary Outcome Measure Information:

Title

Serum PCSK9 concentration

Time Frame

Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled

Secondary Outcome Measure Information:

Title

Serum LDL cholesterol concentration

Time Frame

Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Title

Serum HDL cholesterol concentration

Time Frame

Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Title

Serum TG concentration

Time Frame

Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Title

Serum Apo B concentration

Time Frame

Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hypercholesterolemia Statin monotherapy Exclusion Criteria: Significant acute or chronic illness Secondary causes of hypercholesterolemia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W1R7

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

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