A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome

A Randomised, Double-Blind, Placebo Controlled, Crossover Dose-Ranging Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00240305

Enrollment

Registered

2005-10-18

Start date

2004-04-30

Completion date

2006-05-31

Last updated

2009-03-16

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, Dyslipidaemia

Brief summary

The purpose of this study is to investigate the dose-related effect of treatment with rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein cholesterol (HDL-C) concentration.

Interventions

DRUGRosuvastatin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

30 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Signed informed consent * male aged 30 to 70 years of age * LDL-C \<6 mmol/L * HDL-C ≤1.2 mmol/L * at least 2 of the following: * insulin resistance (fasting glucose \>6 mmol/L or insulin \>10 mU/L or HOMA score \>2.5) * central obesity (waist circumference \>=94 cm). * plasma triglycerides \>=1.7 and \<4.5 mmol/L. * blood pressure \>=130/ \>=85 mm Hg or on drug treatment for hypertension

Exclusion criteria

* LDL cholesterol \>=6 mmol/L * pre-existing or history of cardiovascular disease, diabetes, renal dysfunction, anaemia, history of significant dyspepsia or gastrointestinal disease * apolipoprotein genotype E2/E2

Design outcomes

Primary

Measure	Time frame
Determine the dose-related effect of treatment with rosuvastatin on production & fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), & on the plasma apoA-I, apoA-II & high-density lipoprotein cholesterol (HDL-C) c	—

Secondary

Measure	Time frame
Determine the dose-related effect of treatment with rosuvastatin on cellular cholesterol efflux,total cholesterol, low-density lipoprotein cholesterol (LDL-C), non-LDL-C, triglyceride & pre1-HDL concentrations,HDL2,HDL3 cholesterol ratio	—
Cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) activity	—
Lathosterol and campesterol, total apolipoprotein B (apoB), nonesterified fatty acids (NEFA) and apolipoprotein C-III (apoC-III) plasma concentrations.	—

Countries

Australia

Outcome results

None listed

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