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CompletedNCT00240266Updated Nov 19, 2010

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

A Phase 3 interventional study of Rosuvastatin in Metabolic Syndrome and Dyslipidemia, sponsored by AstraZeneca. Completed at 1 site in Australia. Open to male participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-11-19.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Metabolic Syndrome
  • Dyslipidemia

Keywords

  • Metabolic Syndrome
  • Dyslipaemia
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 15 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Male
Accepts 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

Exclusion Criteria:

  • total cholesterol >7mmol/L
  • pre-existing cardiovascular disease, diabetes, proteinuria or renal failure
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
15 participants

Interventions

  • DrugRosuvastatin

    Also known as: Crestor

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Determine the effect of treatment with rosuvastatin on:

  2. - cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.

  3. - 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.

  4. - plasma concentration of preβ1-HDL.

  5. - plasma concentration of LDL cholesterol, HDL-C and apoA-1.

07

Study locations

1 site
  • Research Site
    Melbourne, Victoria, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00240266
Lead sponsor
AstraZeneca
First posted
Oct 18, 2005
Start date
Aug 2003
Primary completion
Nov 2004
Completion
Dec 2004
Last update
Nov 19, 2010

Study contacts

Paul J Nestel, MD
principal investigator · Baker Heart Research Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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