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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metabolic Syndrome Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes