Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00240266




Registration number
NCT00240266
Ethics application status
Date submitted
16/10/2005
Date registered
18/10/2005
Date last updated
19/11/2010

Titles & IDs
Public title
Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Scientific title
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)
Secondary ID [1] 0 0
4522AS/0003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 0 0
Dyslipidemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosuvastatin

Treatment: Drugs: Rosuvastatin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Determine the effect of treatment with rosuvastatin on:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
- cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
- 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.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
- plasma concentration of preß1-HDL.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
- plasma concentration of LDL cholesterol, HDL-C and apoA-1.
Timepoint [5] 0 0

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- total cholesterol >7mmol/L

- pre-existing cardiovascular disease, diabetes, proteinuria or renal failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2004
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00240266
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul J Nestel, MD
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00240266