HypercholesterolemiaNCT00762229
Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)
A study testing Ezetimibe 10 mg and Ezetimibe 5 mg in people with Hypercholesterolemia, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Ezetimibe 10 mg and Ezetimibe 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects receiving ezetimibe 10 mg
- Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):
- 90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
- 60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
- 30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
- Patients willing and able to provide signed informed consent
Who cannot join
- Patients not receiving ezetimibe
- Patients receiving ezetimibe 5 milligrams
- Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
- Cancer undergoing active treatment
- Participation in any clinical study within the last 30 days
- Drug addiction or alcohol abuse within the past 6 months
Show all 9Show fewer
- Patients unwilling or unable to provide informed consent
- Patients with poor compliance
- Women of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg
The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe 10 mg, Ezetimibe 5 mg
- Keywords
- Cholesterol, Ezetimibe
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe 10 mgDrug
Also called Zetia
Ezetimibe 10 mg daily for 4 weeks
Ezetimibe 5 mgDrug
Also called Zetia
Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe 10 mg | Active comparator | A whole ezetimibe 10 mg tablet Receives: Drug: Ezetimibe 10 mg |
| Ezetimibe 5 mg | Experimental | Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half Receives: Drug: Ezetimibe 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Cholesterol
LDL cholesterol
Measured: 4 weeks
Secondary outcomes (1)
Total Cholesterol
Total cholesterol fasting
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Lawrence Baruch, Bronx VA Medical Center
- Investigators
- Lawrence Baruch, MD, Principal investigator, Bronx VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762229
- Sponsor's protocol ID
- VA---19-07-051
- Status last verified
- Jun 2013
- First submitted
- 29 Sep 2008
- Last updated
- 14 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Baruch L, Agarwal S, Gupta B, Haynos A, Eng C. Effect on serum lipid levels of switching dose of ezetimibe from 10 to 5 mg. Am J Cardiol. 2009 Jun 1;103(11):1568-71. doi: 10.1016/j.amjcard.2009.01.365. Epub 2009 Apr 22.
PubMed 19463517
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg
- ClinicalTrials.gov ID
- NCT00762229
- Acronym / sponsor ID
- VA---19-07-051
- Conditions
- Hypercholesterolemia
- Keywords
- Cholesterol, Ezetimibe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 14 Jun 2013
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 compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe 10 mg | Active comparator | Drug: Ezetimibe 10 mgA whole ezetimibe 10 mg tablet |
| Ezetimibe 5 mg | Experimental | Drug: Ezetimibe 5 mgEzetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects receiving ezetimibe 10 mg
- Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):
- Patients willing and able to provide signed informed consent
Key exclusion criteria (9 listed)
- Patients not receiving ezetimibe
- Patients receiving ezetimibe 5 milligrams
- Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
- Cancer undergoing active treatment
- Participation in any clinical study within the last 30 days
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 |
|---|---|---|
| Ezetimibe 10 mgAlso: ZetiaEzetimibe 10 mg daily for 4 weeks | Drug | Ezetimibe 10 mg |
| Ezetimibe 5 mgAlso: ZetiaEzetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half | Drug | Ezetimibe 5 mg |
Primary outcome
LDL Cholesterol
Time frame: 4 weeks
LDL cholesterol
1 secondary outcome
Total Cholesterol
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19463517Baruch L, Agarwal S, Gupta B, Haynos A, Eng C. Effect on serum lipid levels of switching dose of ezetimibe from 10 to 5 mg. Am J Cardiol. 2009 Jun 1;103(11):1568-71. doi: 10.1016/j.amjcard.2009.01.365. Epub 2009 Apr 22.
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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
Bronx 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 study testing Ezetimibe 10 mg and Ezetimibe 5 mg 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 6 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 14 Jun 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
LDL Cholesterol (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00762229, which also lists 1 linked publication.
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 14 Jun 2013.