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An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

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ClinicalTrials.gov Identifier: NCT00847782
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : November 5, 2009
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Atherosclerosis Procedure: Blood draw Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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 Start Date : March 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Blood draw (Group 1)

Normocholesterolemic Subjects

Normal Healthy Volunteers

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



Primary Outcome Measures :
  1. 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 Measures :
  1. Serum LDL cholesterol concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ]
  2. Serum HDL cholesterol concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ]
  3. Serum TG concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ]
  4. Serum Apo B concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hypercholesterolemia
  • Statin monotherapy

Exclusion Criteria:

  • Significant acute or chronic illness
  • Secondary causes of hypercholesterolemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847782


Locations
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2W1R7
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00847782     History of Changes
Other Study ID Numbers: CV198-001
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: November 5, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases