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OpenTrials
Completed

NCT Number: NCT00847782

An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

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

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Local Institution

Montreal, Quebec, H2W1R7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypercholesterolemia
  • Statin monotherapy

Exclusion criteria

  • Significant acute or chronic illness
  • Secondary causes of hypercholesterolemia

Treatment and study plan

Blood draw

Procedure

1 day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 19, 2009
Registry last updated
Nov 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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