NCT00214617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

June 20, 2017

Status Verified

September 1, 2006

First QC Date

September 19, 2005

Last Update Submit

June 19, 2017

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemiaHMG CoA Reductase Inhibtorstracer kineticsApolipoproteins

Outcome Measures

Primary Outcomes (4)

  • Rate of production of VLDL apoB

  • Rate of clearance of VLDL apoB

  • Rate of production of LDL apoB

  • Rate of clearance of LDL apoB

Secondary Outcomes (3)

  • Rate of production of HDL apoA-I

  • Rate of clearance of HDL apoA-I

  • Activity of cholesteryl ester transfer protein

Interventions

Rosuvastatin at 5 mg/day and 40 mg/dayDRUG

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta Research and Education Foundation

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anh Le, PhD

    Emory University School of Medicine and Atlanta VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

January 1, 2005

Study Completion

February 1, 2006

Last Updated

June 20, 2017

Record last verified: 2006-09

Locations

US(1)