Back to resultsA Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Dyslipidaemia
Eligibility Criteria
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
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00240305
Brief Title
A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Dyslipidemia
Keywords
Metabolic Syndrome, Dyslipidaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) activity
Title
Lathosterol and campesterol, total apolipoprotein B (apoB), nonesterified fatty acids (NEFA) and apolipoprotein C-III (apoC-III) plasma concentrations.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald F. Watts, BSc PhD MD
Organizational Affiliation
University Department of Medicine, Royal Perth Hospital, University of Western Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Perth
State/Province
Western Australia
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25816050
Citation
Ng TW, Ooi EM, Watts GF, Chan DC, Meikle PJ, Barrett PH. Association of Plasma Ceramides and Sphingomyelin With VLDL apoB-100 Fractional Catabolic Rate Before and After Rosuvastatin Treatment. J Clin Endocrinol Metab. 2015 Jun;100(6):2497-501. doi: 10.1210/jc.2014-4348. Epub 2015 Mar 27.
Results Reference
derived
PubMed Identifier
25140396
Citation
Ng TW, Ooi EM, Watts GF, Chan DC, Weir JM, Meikle PJ, Barrett PH. Dose-dependent effects of rosuvastatin on the plasma sphingolipidome and phospholipidome in the metabolic syndrome. J Clin Endocrinol Metab. 2014 Nov;99(11):E2335-40. doi: 10.1210/jc.2014-1665. Epub 2014 Aug 20.
Results Reference
derived
PubMed Identifier
18509206
Citation
Ooi EM, Watts GF, Chan DC, Chen MM, Nestel PJ, Sviridov D, Barrett PH. Dose-dependent effect of rosuvastatin on VLDL-apolipoprotein C-III kinetics in the metabolic syndrome. Diabetes Care. 2008 Aug;31(8):1656-61. doi: 10.2337/dc08-0358. Epub 2008 May 28.
Results Reference
derived
PubMed Identifier
17416370
Citation
Ooi EM, Barrett PH, Chan DC, Nestel PJ, Watts GF. Dose-dependent effect of rosuvastatin on apolipoprotein B-100 kinetics in the metabolic syndrome. Atherosclerosis. 2008 Mar;197(1):139-46. doi: 10.1016/j.atherosclerosis.2007.03.004. Epub 2007 Apr 9.
Results Reference
derived
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A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
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