HypercholesterolemiaPhase 2NCT00325455
MK0859 Dose-Ranging Study (0859-003)
A Phase 2 study testing MK0859 in people with Hypercholesterolemia and Mixed Hyperlipemia, run by Merck Sharp & Dohme LLC.
Trial summary
To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Mixed Hyperlipemia
- What is being tested?
- MK0859
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Mar 2007
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol
Who cannot join
- Patients with CHD or CHD-equivalent disease (except diabetes)
- Diabetics on statins
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of MK-0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.
- Conditions
- Hypercholesterolemia, Mixed Hyperlipemia
- Being tested
- MK0859
- Medical subject headings
- Hypercholesterolemia, Hyperlipoproteinemia Type V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0859Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the cholesterol changing effects of MK0859
Secondary outcomes (1)
Acceptable safety profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325455
- Sponsor's protocol ID
- 0859-003
- Other IDs
- 2006_006
- Status last verified
- Feb 2015
- First submitted
- 11 May 2006
- Last updated
- 2 Mar 2015
- Results posted
- No
Publications
Dansky HM, Bloomfield D, Gibbons P, Liu S, Sisk CM, Tribble D, McKenney JM, Littlejohn TW 3rd, Mitchel Y. Efficacy and safety after cessation of treatment with the cholesteryl ester transfer protein inhibitor anacetrapib (MK-0859) in patients with primary hypercholesterolemia or mixed hyperlipidemia. Am Heart J. 2011 Oct;162(4):708-16. doi: 10.1016/j.ahj.2011.07.010. Epub 2011 Sep 1.
PubMed 21982664Krauss RM, Pinto CA, Liu Y, Johnson-Levonas AO, Dansky HM. Changes in LDL particle concentrations after treatment with the cholesteryl ester transfer protein inhibitor anacetrapib alone or in combination with atorvastatin. J Clin Lipidol. 2015 Jan-Feb;9(1):93-102. doi: 10.1016/j.jacl.2014.09.013. Epub 2014 Oct 13.
PubMed 25670366
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of MK-0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00325455
- Acronym / sponsor ID
- 0859-003
- Conditions
- Hypercholesterolemia, Mixed Hyperlipemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 12 May 2006 (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.
To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol
Key exclusion criteria (2 listed)
- Patients with CHD or CHD-equivalent disease (except diabetes)
- Diabetics on statins
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 |
|---|---|---|
| MK0859 | Drug | – |
Primary outcome
To assess the cholesterol changing effects of MK0859
1 secondary outcome
Acceptable safety profile
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Results publication: PubMed 21982664Dansky HM, Bloomfield D, Gibbons P, Liu S, Sisk CM, Tribble D, McKenney JM, Littlejohn TW 3rd, Mitchel Y. Efficacy and safety after cessation of treatment with the cholesteryl ester transfer protein inhibitor anacetrapib (MK-0859) in patients with primary hypercholesterolemia or mixed hyperlipidemia. Am Heart J. 2011 Oct;162(4):708-16. doi: 10.1016/j.ahj.2011.07.010. Epub 2011 Sep 1.
- Derived from this study: PubMed 25670366Krauss RM, Pinto CA, Liu Y, Johnson-Levonas AO, Dansky HM. Changes in LDL particle concentrations after treatment with the cholesteryl ester transfer protein inhibitor anacetrapib alone or in combination with atorvastatin. J Clin Lipidol. 2015 Jan-Feb;9(1):93-102. doi: 10.1016/j.jacl.2014.09.013. Epub 2014 Oct 13.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0859 in people with Hypercholesterolemia and Mixed Hyperlipemia, run by Merck Sharp & Dohme LLC.
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 1 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: stopped early, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
To assess the cholesterol changing effects of MK0859. 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 NCT00325455, which also lists 2 linked publications.
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 2 Mar 2015.