HypercholesterolemiaPhase 1NCT00565292
A Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)
A Phase 1 study testing MK0859 in people with Hypercholesterolemia and Hyperlipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL cholesterol in blood) This is an early phase trial and some… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemia
- What is being tested?
- MK0859
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Aug 2006
- Phase
- Phase 1
- 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
- Patient is between 18 and 75 years of age
- Patient can be on a stable diet for the study
- Patient has a stable weight for more then 6 weeks before the study and has not participated in a weight loss program
Who cannot join
- Patient has chronic heart failure or a history of heart disease
- Patient has blood, digestive, or central nervous system disorders
- Patient is pregnant or nursing
- Patient is HIV positive
About this study
This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL cholesterol in blood) This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
- Conditions
- Hypercholesterolemia, Hyperlipidemia
- Being tested
- MK0859
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0859Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startJul 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 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
- NCT00565292
- Sponsor's protocol ID
- 0859-011
- Other IDs
- 2007_655
- Status last verified
- Feb 2015
- First submitted
- 27 Nov 2007
- Last updated
- 25 Feb 2015
- Results posted
- No
Publications
Krishna R, Anderson MS, Bergman AJ, Jin B, Fallon M, Cote J, Rosko K, Chavez-Eng C, Lutz R, Bloomfield DM, Gutierrez M, Doherty J, Bieberdorf F, Chodakewitz J, Gottesdiener KM, Wagner JA. Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomised placebo-controlled phase I studies. Lancet. 2007 Dec 8;370(9603):1907-14. doi: 10.1016/S0140-6736(07)61813-3.
PubMed 18068514
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)
- ClinicalTrials.gov ID
- NCT00565292
- Acronym / sponsor ID
- 0859-011
- Conditions
- Hypercholesterolemia, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 29 Nov 2007 (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.
This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL cholesterol in blood) This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is between 18 and 75 years of age
- Patient can be on a stable diet for the study
- Patient has a stable weight for more then 6 weeks before the study and has not participated in a weight loss program
Key exclusion criteria (4 listed)
- Patient has chronic heart failure or a history of heart disease
- Patient has blood, digestive, or central nervous system disorders
- Patient is pregnant or nursing
- Patient is HIV positive
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
Not reported in the source record.
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 25 Feb 2015.
- Derived from this study: PubMed 18068514Krishna R, Anderson MS, Bergman AJ, Jin B, Fallon M, Cote J, Rosko K, Chavez-Eng C, Lutz R, Bloomfield DM, Gutierrez M, Doherty J, Bieberdorf F, Chodakewitz J, Gottesdiener KM, Wagner JA. Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomised placebo-controlled phase I studies. Lancet. 2007 Dec 8;370(9603):1907-14. doi: 10.1016/S0140-6736(07)61813-3.
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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 1 study testing MK0859 in people with Hypercholesterolemia and Hyperlipidemia, 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 3 inclusion and 4 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 25 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565292, 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 25 Feb 2015.