Skip to content

Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)

A Randomised, Double-blind, Placebo-controlled, Crossover Pilot Study to Define the High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00240266
Enrollment
15
Registered
2005-10-18
Start date
2003-08-31
Completion date
2004-12-31
Last updated
2010-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Metabolic Syndrome

Keywords

Metabolic Syndrome, Dyslipaemia

Brief summary

The purpose of this study is to investigate the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.

Interventions

DRUGRosuvastatin

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Signed informed consent * males aged 45-65 * insulin resistance * central obesity * LDL-C \<6 mmol/L * plasma triglycerides \>=1.7 and ≤5.5 mmol/L * HDL-C ≤1.2 mmol/L.

Exclusion criteria

* total cholesterol \>7mmol/L * pre-existing cardiovascular disease, diabetes, proteinuria or renal failure

Design outcomes

Primary

MeasureTime frame
Determine the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.

Secondary

MeasureTime frame
Determine the effect of treatment with rosuvastatin on:
- cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
- plasma concentration of cholesterol ester transfer protein and capacity to transfer cholesterol from HDL-C to apoB-containing lipoproteins, one of the steps in RCT.
- plasma concentration of preβ1-HDL.
- plasma concentration of LDL cholesterol, HDL-C and apoA-1.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026