An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

NCT ID: NCT00847782

Last Updated: 2009-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Blood draw (Group 1)

Normocholesterolemic Subjects

Normal Healthy Volunteers

Group Type OTHER

Blood draw

Intervention Type PROCEDURE

1 day

Blood draw (Group 2)

Hypercholesterolemic Subjects

Group Type OTHER

Blood draw

Intervention Type PROCEDURE

1 day

Blood draw (Group 3)

Hypercholesterolemic Subjects with Statin Treatment

Group Type OTHER

Blood draw

Intervention Type PROCEDURE

1 day

Interventions

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Blood draw

1 day

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Hypercholesterolemia
* Statin monotherapy

Exclusion Criteria

* Significant acute or chronic illness
* Secondary causes of hypercholesterolemia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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CV198-001

Identifier Type: -

Identifier Source: org_study_id

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