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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00240305




Registration number
NCT00240305
Ethics application status
Date submitted
16/10/2005
Date registered
18/10/2005
Date last updated
16/03/2009

Titles & IDs
Public title
A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
Scientific 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
Secondary ID [1] 0 0
4522AS/0004
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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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 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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) activity
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Lathosterol and campesterol, total apolipoprotein B (apoB), nonesterified fatty acids (NEFA) and apolipoprotein C-III (apoC-III) plasma concentrations.
Timepoint [3] 0 0

Eligibility
Key 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
Minimum age
30 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
- Perth

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 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.
Trial website
https://clinicaltrials.gov/show/NCT00240305
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald F. Watts, BSc PhD MD
Address 0 0
University Department of Medicine, Royal Perth Hospital, University of Western Australia
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
Other publications