DyslipidemiaPhase 2NCT00977288
A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
A Phase 2 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 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia. Read more about this study
- Who is it for?
- Ages 20 to 75 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
- 408 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Apr 2014
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia
Who cannot join
- Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)
- Patients has uncontrolled diabetes
- Patient is currently participating or has participated in a study with an investigational compound within the last 3 months
About this study
Official title: A Phase IIb, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Assess the Efficacy and Safety of MK0859 in Japanese Patients With Dyslipidemia
This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.
Read the detailed description
This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients.
Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period.
As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.
- Conditions
- Dyslipidemia
- Being tested
- anacetrapib, Comparator: atorvastatin, Comparator: Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anacetrapibDrug
Also called MK0859
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Comparator: atorvastatinDrug
atorvastatin tablet, 10mg, once daily for 8 weeks
Comparator: PlaceboDrug
Placebo tablet, once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MK0859 10 mg + placebo Receives: Drug: anacetrapib; Drug: Comparator: Placebo |
| 2 | Experimental | MK0859 40 mg + placebo Receives: Drug: anacetrapib; Drug: Comparator: Placebo |
| 3 | Experimental | MK0859 100 mg + placebo Receives: Drug: anacetrapib; Drug: Comparator: Placebo |
| 4 | Experimental | MK0859 300 mg + placebo Receives: Drug: anacetrapib; Drug: Comparator: Placebo |
| 5 | Experimental | MK0859 10 mg + atorvastatin 10mg Receives: Drug: anacetrapib; Drug: Comparator: atorvastatin |
| 6 | Experimental | MK0859 40 mg + atorvastatin 10mg Receives: Drug: anacetrapib; Drug: Comparator: atorvastatin |
| 7 | Experimental | MK0859 100 mg + atorvastatin 10mg Receives: Drug: anacetrapib; Drug: Comparator: atorvastatin |
| 8 | Experimental | MK0859 300 mg + atorvastatin 10mg Receives: Drug: anacetrapib; Drug: Comparator: atorvastatin |
| 9 | Placebo comparator | Placebo + atorvastatin 10mg Receives: Drug: Comparator: atorvastatin; Drug: Comparator: Placebo |
| 10 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
Measured: 8 weeks
Secondary outcomes (1)
The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionApr 2014
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 408 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
- NCT00977288
- Sponsor's protocol ID
- 0859-029
- Other IDs
- 2009_662
- Status last verified
- May 2015
- First submitted
- 14 Sep 2009
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Teramoto T, Shirakawa M, Kikuchi M, Nakagomi M, Tamura S, Surks HK, McCrary Sisk C, Numaguchi H. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia. Atherosclerosis. 2013 Sep;230(1):52-60. doi: 10.1016/j.atherosclerosis.2013.05.012. Epub 2013 Jun 5.
PubMed 23958252
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Assess the Efficacy and Safety of MK0859 in Japanese Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT00977288
- Acronym / sponsor ID
- 0859-029
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 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.
This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.
Detailed description
This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients.
Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period.
As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: anacetrapib, Drug: Comparator: PlaceboMK0859 10 mg + placebo |
| 2 | Experimental | Drug: anacetrapib, Drug: Comparator: PlaceboMK0859 40 mg + placebo |
| 3 | Experimental | Drug: anacetrapib, Drug: Comparator: PlaceboMK0859 100 mg + placebo |
| 4 | Experimental | Drug: anacetrapib, Drug: Comparator: PlaceboMK0859 300 mg + placebo |
| 5 | Experimental | Drug: anacetrapib, Drug: Comparator: atorvastatinMK0859 10 mg + atorvastatin 10mg |
| 6 | Experimental | Drug: anacetrapib, Drug: Comparator: atorvastatinMK0859 40 mg + atorvastatin 10mg |
| 7 | Experimental | Drug: anacetrapib, Drug: Comparator: atorvastatinMK0859 100 mg + atorvastatin 10mg |
| 8 | Experimental | Drug: anacetrapib, Drug: Comparator: atorvastatinMK0859 300 mg + atorvastatin 10mg |
| 9 | Placebo comparator | Drug: Comparator: atorvastatin, Drug: Comparator: PlaceboPlacebo + atorvastatin 10mg |
| 10 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia
Key exclusion criteria (3 listed)
- Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)
- Patients has uncontrolled diabetes
- Patient is currently participating or has participated in a study with an investigational compound within the last 3 months
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 |
|---|---|---|
| anacetrapibAlso: MK085910, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks | Drug | 1, 2, 3, 4, 5, 6, 7, 8 |
| Comparator: atorvastatinatorvastatin tablet, 10mg, once daily for 8 weeks | Drug | 5, 6, 7, 8, 9 |
| Comparator: PlaceboPlacebo tablet, once daily for 8 weeks | Drug | 1, 10, 2, 3, 4, 9 |
Primary outcome
The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
Time frame: 8 weeks
1 secondary outcome
The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8
Time frame: 8 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 6 May 2015.
- Results publication: PubMed 23958252Teramoto T, Shirakawa M, Kikuchi M, Nakagomi M, Tamura S, Surks HK, McCrary Sisk C, Numaguchi H. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia. Atherosclerosis. 2013 Sep;230(1):52-60. doi: 10.1016/j.atherosclerosis.2013.05.012. Epub 2013 Jun 5.
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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 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 1 inclusion and 3 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 6 May 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. Some participants in this study may receive a placebo. 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 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?
The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8 (time frame: 8 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 NCT00977288, 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 6 May 2015.