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Effect of Crestor on Lipoprotein Metabolism in Humans

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ClinicalTrials.gov Identifier: NCT00214617
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Atlanta Research and Education Foundation

Study Description
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Brief Summary:
The objective of this research is to understand how Crestor can effectively reduce the levels of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will facilitate the rate of removal of LDL from the blood. At the higher dose, the increased potency of Crestor is explained by a reduction in the production of LDL by the liver.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin at 5 mg/day and 40 mg/day Phase 4

Detailed Description:

Crestor has been demonstrated to be effective in reducing plasma LDL by 20 to 60% in a dose dependent fashion. While the primary mechanism of action of this class of agents is the increase in the expression of LDL receptor resulting in accelerated clearance of LDL, the increase potency of Crestor in comparison to other statins may suggest other mechanisms. We propose to study the rate of incorporation of deuterated labeled leucine into VLDL apoB and LDL apoB and to determine the effect of two doses of Crestor (5 mg/day and 40 mg/day) on the production and clearance of apoB. Participants will be admitted to the General Clinical Research Center on three occasions (4 days, 3 nights per admission) for these metabolic studies. This is an open-label study design to reflect usual care with the first admission taking place while the participant is not on any lipid-lowering therapy. The second admission will occur after a minimum of 6 weeks on the low dose (5mg/day). The dose will be increased to 40 mg/day at the time of discharge and the third admission will occur after a minimum of 6 weeks on the higher dose.

A secondary objective of this study is to examine the rate of production and clearance of apoA-I, the major protein in HDL, at the 2 doses of Crestor. In addition to a reduction in LDL, Crestor has also been reported to result in a characteristic dose-dependent increase in HDL. The mechanism of this increase is not understood.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Crestor on the Kinetics of Plasma Apolipoproteins: Dose-Response Study
Study Start Date : January 2005
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of production of VLDL apoB
  2. Rate of clearance of VLDL apoB
  3. Rate of production of LDL apoB
  4. Rate of clearance of LDL apoB

Secondary Outcome Measures :
  1. Rate of production of HDL apoA-I
  2. Rate of clearance of HDL apoA-I
  3. Activity of cholesteryl ester transfer protein

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • TG between 200 and 400 mg/dL
  • LDLc between 160 and 250 mg/dL
  • HDLc between 30 and 50 mg/dL for men and 40-65 mg/dL for women
  • Lp(a) less than 30 mg/dL
  • Age between 50 and 75 years

Exclusion Criteria:

  • current lipid-lowering therapy,
  • primary hypertriglyceridemia (TG>400 mg/dL),
  • High HDL (HDL>70),
  • high Lp(a), greater than 30 mg/dL
  • presence of beta-VLDL on agarose electrophoresis,
  • current use of immunosuppressive agents,
  • hormone replacement therapy for women
  • history of cancer, active liver disease or hepatic dysfunction (AST or ALT 1.5 x ULN (Upper Limit of Normal),
  • excessive consumption of alcohol, and recent history of drug abuse.
Contacts and Locations
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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): NCT00214617


Locations
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United States, Georgia
Atlanta Research and Education Foundation
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Atlanta Research and Education Foundation
AstraZeneca
Investigators
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Principal Investigator: Anh Le, PhD Emory University School of Medicine and Atlanta VAMC
More Information
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ClinicalTrials.gov Identifier: NCT00214617    
Other Study ID Numbers: AREF_Le_IRUSROSU 0021
IRUSROSU 0021
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: September 2006
Keywords provided by Atlanta Research and Education Foundation:
hypercholesterolemia
HMG CoA Reductase Inhibtors
tracer kinetics
Apolipoproteins
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors