Metabolic SyndromePhase 3NCT00240266
Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
A Phase 3 study testing Rosuvastatin in people with Metabolic Syndrome and Dyslipidemia, run by AstraZeneca at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Metabolic Syndrome, Dyslipidemia
- What is being tested?
- Rosuvastatin
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2003to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- total cholesterol >7mmol/L
- pre-existing cardiovascular disease, diabetes, proteinuria or renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
- Conditions
- Metabolic Syndrome, Dyslipidemia
- Being tested
- Rosuvastatin
- Keywords
- Metabolic Syndrome, Dyslipaemia
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (5)
Determine the effect of treatment with rosuvastatin on:
- cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
- 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.
- plasma concentration of preβ1-HDL.
- plasma concentration of LDL cholesterol, HDL-C and apoA-1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startAug 2003
- Primary completionNov 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul J Nestel, MD, Principal investigator, Baker Heart Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240266
- Sponsor's protocol ID
- 4522AS/0003
- Status last verified
- Nov 2010
- First submitted
- 16 Oct 2005
- Last updated
- 19 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00240266
- Acronym / sponsor ID
- 4522AS/0003
- Conditions
- Metabolic Syndrome, Dyslipidemia
- Keywords
- Metabolic Syndrome, Dyslipaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- males aged 45-65
- insulin resistance
- central obesity
- LDL-C <6 mmol/L
Key exclusion criteria (2 listed)
- total cholesterol >7mmol/L
- pre-existing cardiovascular disease, diabetes, proteinuria or renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor | Drug | – |
Primary outcome
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.
5 secondary outcomes
Determine the effect of treatment with rosuvastatin on:
- cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
- 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.
- plasma concentration of preβ1-HDL.
- plasma concentration of LDL cholesterol, HDL-C and apoA-1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Nestel, MD principal investigator
Baker Heart Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Metabolic Syndrome and Dyslipidemia, run by AstraZeneca at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.