HypercholesterolemiaPhase 4NCT00214617
Effect of Crestor on Lipoprotein Metabolism in Humans
A Phase 4 study testing Rosuvastatin at 5 mg/day and 40 mg/day in people with Hypercholesterolemia, run by Foundation for Atlanta Veterans Education and Research, Inc. at 1 site in United States.
Trial summary
The objective of this research is to understand how Crestor can effectively reduce the levels of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will facilitate the rate of removal of LDL from the blood. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin at 5 mg/day and 40 mg/day
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Feb 2006
- Phase
- Phase 4
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- TG between 200 and 400 mg/dL
- LDLc between 160 and 250 mg/dL
- HDLc between 30 and 50 mg/dL for men and 40-65 mg/dL for women
- Lp(a) less than 30 mg/dL
- Age between 50 and 75 years
Who cannot join
- current lipid-lowering therapy,
- primary hypertriglyceridemia (TG>400 mg/dL),
- High HDL (HDL>70),
- high Lp(a), greater than 30 mg/dL
- presence of beta-VLDL on agarose electrophoresis,
- current use of immunosuppressive agents,
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- hormone replacement therapy for women
- history of cancer, active liver disease or hepatic dysfunction (AST or ALT 1.5 x ULN (Upper Limit of Normal),
- excessive consumption of alcohol, and recent history of drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Research and Education Foundation
Decatur, Georgia, 30033
About this study
Official title: Effect of Crestor on the Kinetics of Plasma Apolipoproteins: Dose-Response Study
The objective of this research is to understand how Crestor can effectively reduce the levels of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will facilitate the rate of removal of LDL from the blood. At the higher dose, the increased potency of Crestor is explained by a reduction in the production of LDL by the liver.
Read the detailed description
Crestor has been demonstrated to be effective in reducing plasma LDL by 20 to 60% in a dose dependent fashion. While the primary mechanism of action of this class of agents is the increase in the expression of LDL receptor resulting in accelerated clearance of LDL, the increase potency of Crestor in comparison to other statins may suggest other mechanisms. We propose to study the rate of incorporation of deuterated labeled leucine into VLDL apoB and LDL apoB and to determine the effect of two doses of Crestor (5 mg/day and 40 mg/day) on the production and clearance of apoB. Participants will be admitted to the General Clinical Research Center on three occasions (4 days, 3 nights per admission) for these metabolic studies. This is an open-label study design to reflect usual care with the first admission taking place while the participant is not on any lipid-lowering therapy. The second admission will occur after a minimum of 6 weeks on the low dose (5mg/day). The dose will be increased to 40 mg/day at the time of discharge and the third admission will occur after a minimum of 6 weeks on the higher dose.
A secondary objective of this study is to examine the rate of production and clearance of apoA-I, the major protein in HDL, at the 2 doses of Crestor. In addition to a reduction in LDL, Crestor has also been reported to result in a characteristic dose-dependent increase in HDL. The mechanism of this increase is not understood.
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin at 5 mg/day and 40 mg/day
- Keywords
- hypercholesterolemia, HMG CoA Reductase Inhibtors, tracer kinetics, Apolipoproteins
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin at 5 mg/day and 40 mg/dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of production of VLDL apoB
Rate of clearance of VLDL apoB
Rate of production of LDL apoB
Rate of clearance of LDL apoB
Secondary outcomes (3)
Rate of production of HDL apoA-I
Rate of clearance of HDL apoA-I
Activity of cholesteryl ester transfer protein
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants
Sponsor and investigators
- Lead sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Anh Le, PhD, Principal investigator, Emory University School of Medicine and Atlanta VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214617
- Sponsor's protocol ID
- AREF_Le_IRUSROSU 0021
- Other IDs
- IRUSROSU 0021
- Status last verified
- Sep 2006
- First submitted
- 19 Sep 2005
- Last updated
- 20 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Crestor on the Kinetics of Plasma Apolipoproteins: Dose-Response Study
- ClinicalTrials.gov ID
- NCT00214617
- Acronym / sponsor ID
- AREF_Le_IRUSROSU 0021
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, HMG CoA Reductase Inhibtors, tracer kinetics, Apolipoproteins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants
- Lead sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.University, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jan 2005
- Study completion
- Feb 2006
- First posted
- 22 Sep 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 objective of this research is to understand how Crestor can effectively reduce the levels of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will facilitate the rate of removal of LDL from the blood. At the higher dose, the increased potency of Crestor is explained by a reduction in the production of LDL by the liver.
Detailed description
Crestor has been demonstrated to be effective in reducing plasma LDL by 20 to 60% in a dose dependent fashion. While the primary mechanism of action of this class of agents is the increase in the expression of LDL receptor resulting in accelerated clearance of LDL, the increase potency of Crestor in comparison to other statins may suggest other mechanisms. We propose to study the rate of incorporation of deuterated labeled leucine into VLDL apoB and LDL apoB and to determine the effect of two doses of Crestor (5 mg/day and 40 mg/day) on the production and clearance of apoB. Participants will be admitted to the General Clinical Research Center on three occasions (4 days, 3 nights per admission) for these metabolic studies. This is an open-label study design to reflect usual care with the first admission taking place while the participant is not on any lipid-lowering therapy. The second admission will occur after a minimum of 6 weeks on the low dose (5mg/day). The dose will be increased to 40 mg/day at the time of discharge and the third admission will occur after a minimum of 6 weeks on the higher dose.
A secondary objective of this study is to examine the rate of production and clearance of apoA-I, the major protein in HDL, at the 2 doses of Crestor. In addition to a reduction in LDL, Crestor has also been reported to result in a characteristic dose-dependent increase in HDL. The mechanism of this increase is not understood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- TG between 200 and 400 mg/dL
- LDLc between 160 and 250 mg/dL
- HDLc between 30 and 50 mg/dL for men and 40-65 mg/dL for women
- Lp(a) less than 30 mg/dL
- Age between 50 and 75 years
Key exclusion criteria (9 listed)
- current lipid-lowering therapy,
- primary hypertriglyceridemia (TG>400 mg/dL),
- High HDL (HDL>70),
- high Lp(a), greater than 30 mg/dL
- presence of beta-VLDL on agarose electrophoresis,
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 |
|---|---|---|
| Rosuvastatin at 5 mg/day and 40 mg/day | Drug | – |
Primary outcome
Rate of production of VLDL apoB
Rate of clearance of VLDL apoB
Rate of production of LDL apoB
Rate of clearance of LDL apoB
3 secondary outcomes
Rate of production of HDL apoA-I
Rate of clearance of HDL apoA-I
Activity of cholesteryl ester transfer protein
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 20 Jun 2017.
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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.
Anh Le, PhD principal investigator
Emory University School of Medicine and Atlanta VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin at 5 mg/day and 40 mg/day in people with Hypercholesterolemia, run by Foundation for Atlanta Veterans Education and Research, Inc. at 1 site in United States.
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 5 inclusion and 9 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 20 Jun 2017. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Rate of production of VLDL apoB. The study lists 4 primary outcomes in all. 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 20 Jun 2017.