DyslipidemiaPhase 1NCT00990808
The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
A Phase 1 study testing anacetrapib and Comparator: atorvastatin in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- anacetrapib and Comparator: atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jul 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's weight has been stable for at least 6 weeks
- Patient is in good health based on medical history, physical exam, and laboratory tests
- Patient has dyslipidemia
Who cannot join
- Patient has a history of stroke, seizures, or major neurological disorders
- Patient has a history of cancer
- Patient is currently taking any lipid-lowering medications or substances except for statins
- Patient consumes excessive amounts of alcohol or caffeine
- Patient has multiple and/or severe allergies to food or drugs
About this study
Official title: A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients
This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.
- Conditions
- Dyslipidemia
- Being tested
- anacetrapib, Comparator: atorvastatin, Comparator: placebo to MK0859, Comparator: placebo to atorvastatin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anacetrapibDrug
[Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.
Comparator: atorvastatinDrug
Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
Comparator: placebo to MK0859Drug
Placebo to MK0859 once daily for 4 weeks.
Comparator: placebo to atorvastatinDrug
Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Panel A | Experimental | Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859 Receives: Drug: anacetrapib; Drug: Comparator: atorvastatin; Drug: Comparator: placebo to MK0859 |
| Panel B | Experimental | Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin Receives: Drug: anacetrapib; Drug: Comparator: placebo to MK0859; Drug: Comparator: placebo to atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
Measured: 12 weeks
Secondary outcomes (1)
Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJul 2011
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 DyslipidemiaStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 46 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
- NCT00990808
- Sponsor's protocol ID
- 0859-026
- Other IDs
- 0859-026
- Status last verified
- Jun 2015
- First submitted
- 6 Oct 2009
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Millar JS, Reyes-Soffer G, Jumes P, Dunbar RL, deGoma EM, Baer AL, Karmally W, Donovan DS, Rafeek H, Pollan L, Tohyama J, Johnson-Levonas AO, Wagner JA, Holleran S, Obunike J, Liu Y, Ramakrishnan R, Lassman ME, Gutstein DE, Ginsberg HN, Rader DJ. Anacetrapib lowers LDL by increasing ApoB clearance in mildly hypercholesterolemic subjects. J Clin Invest. 2015 Jun;125(6):2510-22. doi: 10.1172/JCI80025. Epub 2015 May 11.
PubMed 25961461Thomas T, Zhou H, Karmally W, Ramakrishnan R, Holleran S, Liu Y, Jumes P, Wagner JA, Hubbard B, Previs SF, Roddy T, Johnson-Levonas AO, Gutstein DE, Marcovina SM, Rader DJ, Ginsberg HN, Millar JS, Reyes-Soffer G. CETP (Cholesteryl Ester Transfer Protein) Inhibition With Anacetrapib Decreases Production of Lipoprotein(a) in Mildly Hypercholesterolemic Subjects. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1770-1775. doi: 10.1161/ATVBAHA.117.309549. Epub 2017 Jul 20.
PubMed 28729361
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients
- ClinicalTrials.gov ID
- NCT00990808
- Acronym / sponsor ID
- 0859-026
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Oct 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.
This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panel A | Experimental | Drug: anacetrapib, Drug: Comparator: atorvastatin, Drug: Comparator: placebo to MK0859Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859 |
| Panel B | Experimental | Drug: anacetrapib, Drug: Comparator: placebo to MK0859, Drug: Comparator: placebo to atorvastatinPeriod 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient's weight has been stable for at least 6 weeks
- Patient is in good health based on medical history, physical exam, and laboratory tests
- Patient has dyslipidemia
Key exclusion criteria (5 listed)
- Patient has a history of stroke, seizures, or major neurological disorders
- Patient has a history of cancer
- Patient is currently taking any lipid-lowering medications or substances except for statins
- Patient consumes excessive amounts of alcohol or caffeine
- Patient has multiple and/or severe allergies to food or drugs
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 |
|---|---|---|
| anacetrapib[Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks. | Drug | Panel A, Panel B |
| Comparator: atorvastatinAtorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2. | Drug | Panel A |
| Comparator: placebo to MK0859Placebo to MK0859 once daily for 4 weeks. | Drug | Panel A, Panel B |
| Comparator: placebo to atorvastatinPlacebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2. | Drug | Panel B |
Primary outcome
Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
Time frame: 12 weeks
1 secondary outcome
Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo
Time frame: 12 weeks
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 4 Jun 2015.
- Background: PubMed 25961461Millar JS, Reyes-Soffer G, Jumes P, Dunbar RL, deGoma EM, Baer AL, Karmally W, Donovan DS, Rafeek H, Pollan L, Tohyama J, Johnson-Levonas AO, Wagner JA, Holleran S, Obunike J, Liu Y, Ramakrishnan R, Lassman ME, Gutstein DE, Ginsberg HN, Rader DJ. Anacetrapib lowers LDL by increasing ApoB clearance in mildly hypercholesterolemic subjects. J Clin Invest. 2015 Jun;125(6):2510-22. doi: 10.1172/JCI80025. Epub 2015 May 11.
- Derived from this study: PubMed 28729361Thomas T, Zhou H, Karmally W, Ramakrishnan R, Holleran S, Liu Y, Jumes P, Wagner JA, Hubbard B, Previs SF, Roddy T, Johnson-Levonas AO, Gutstein DE, Marcovina SM, Rader DJ, Ginsberg HN, Millar JS, Reyes-Soffer G. CETP (Cholesteryl Ester Transfer Protein) Inhibition With Anacetrapib Decreases Production of Lipoprotein(a) in Mildly Hypercholesterolemic Subjects. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1770-1775. doi: 10.1161/ATVBAHA.117.309549. Epub 2017 Jul 20.
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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 anacetrapib and Comparator: atorvastatin in people with Dyslipidemia, 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 5 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 4 Jun 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.
What does the primary outcome measure?
Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone (time frame: 12 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 NCT00990808, 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 4 Jun 2015.