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An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00847782
First received: February 6, 2009
Last updated: November 4, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention
Atherosclerosis
 Procedure: Blood draw

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum LDL cholesterol concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ] [ Designated as safety issue: No ]
  • Serum HDL cholesterol concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ] [ Designated as safety issue: No ]
  • Serum TG concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ] [ Designated as safety issue: No ]
  • Serum Apo B concentration [ Time Frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hypercholesterolemia
  • Statin monotherapy

Exclusion Criteria:

  • Significant acute or chronic illness
  • Secondary causes of hypercholesterolemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00847782     History of Changes
Other Study ID Numbers: CV198-001
Study First Received: February 6, 2009
Last Updated: November 4, 2009
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 26, 2012