An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

November 4, 2009 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W1R7
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypercholesterolemia
  • Statin monotherapy

Exclusion Criteria:

  • Significant acute or chronic illness
  • Secondary causes of hypercholesterolemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Blood draw (Group 1)

Normocholesterolemic Subjects

Normal Healthy Volunteers
Procedure: Blood draw
1 day
Other: Blood draw (Group 2)
Hypercholesterolemic Subjects
Procedure: Blood draw
1 day
Other: Blood draw (Group 3)
Hypercholesterolemic Subjects with Statin Treatment
Procedure: Blood draw
1 day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum LDL cholesterol concentration
Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum HDL cholesterol concentration
Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum TG concentration
Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum Apo B concentration
Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

November 5, 2009

Last Update Submitted That Met QC Criteria

November 4, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV198-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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