HypercholesterolemiaPhase 4NCT00972829
Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
A Phase 4 study testing Rosuvastatin and Ezetimibe in people with Hypercholesterolemia, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin and Ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of intolerance to statins
- Patients currently receiving ezetimibe
- Patients willing and able to provide signed informed consent
Who cannot join
- Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
- Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
- Cancer undergoing active treatment
- Creatinine clearance < 40 ml/minute
- Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
- Participation in any clinical study within the last 30 days
Show all 13Show fewer
- Drug addition or alcohol abuse within the past 6 months
- Use of cyclosporine within the last 3 months
- Use of gemfibrozil within the last month
- Patients unwilling or unable to provide informed consent
- Patients with poor compliance
- Women of childbearing potential
- History of rhabdomyolysis due to statins
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bronx VA Medical Center
The Bronx, New York, 10468
Lawrence Baruch, MD, 718-584-9000 ext. 5970, lawrence.baruch@va.gov
Lawrence Baruch, MD
About this study
Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin, Ezetimibe
- Keywords
- Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin 10 or 20 milligrams once or twice a week
EzetimibeDrug
Also called Zetia
Ezetimibe 5 or 10 milligrams
| Study group | Role | What they receive |
|---|---|---|
| Crestor | Experimental | Crestor 10 or 20 milligrams Receives: Drug: Rosuvastatin |
| Ezetimibe | Active comparator | Ezetimibe 5 or 10 milligrams Receives: Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-density lipoprotein (LDL) cholesterol
Measured: 6 weeks
Low-density lipoprotein (LDL) cholesterol
Measured: 3-4 months
Secondary outcomes (1)
The ability to remain on Crestor for the study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Lawrence Baruch, MD, Principal investigator, James J.Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972829
- Sponsor's protocol ID
- BAR-09-07
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
- ClinicalTrials.gov ID
- NCT00972829
- Acronym / sponsor ID
- BAR-09-07
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 9 Sep 2009 (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.
Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crestor | Experimental | Drug: RosuvastatinCrestor 10 or 20 milligrams |
| Ezetimibe | Active comparator | Drug: EzetimibeEzetimibe 5 or 10 milligrams |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a history of intolerance to statins
- Patients currently receiving ezetimibe
- Patients willing and able to provide signed informed consent
Key exclusion criteria (13 listed)
- Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
- Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
- Cancer undergoing active treatment
- Creatinine clearance < 40 ml/minute
- Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
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: CrestorRosuvastatin 10 or 20 milligrams once or twice a week | Drug | Crestor |
| EzetimibeAlso: ZetiaEzetimibe 5 or 10 milligrams | Drug | Ezetimibe |
Primary outcome
Low-density lipoprotein (LDL) cholesterol
Time frame: 6 weeks
Low-density lipoprotein (LDL) cholesterol
Time frame: 3-4 months
1 secondary outcome
The ability to remain on Crestor for the study period
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2009.
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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.
Lawrence Baruch, MD principal investigator
James J.Peters VA Medical Center
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 and Ezetimibe in people with Hypercholesterolemia, run by Bronx VA Medical Center 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Sep 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-density lipoprotein (LDL) cholesterol (time frame: 6 weeks). The study lists 2 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 10 Sep 2009.