Primary HypercholesterolemiaPhase 3NCT00269217
Lipid Efficacy Study (0524B-022)(COMPLETED)
A Phase 3 study testing niacin (+) laropiprant (+) simvastatin, Comparator: niacin (+) laropiprant and Comparator: simvastatin in people with Primary Hypercholesterolemia and Mixed Hyperlipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Hyperlipidemia
- What is being tested?
- niacin (+) laropiprant (+) simvastatin, Comparator: niacin (+) laropiprant and Comparator: simvastatin
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jan 2007
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
- LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides </= 350 mg/dL.
Who cannot join
- A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
- Patients with <80% compliance
- Patients with certain medical conditions
- Patients taking certain concomitant medications and/or with unstable doses of medications
- Or those with a history of CHD/CHD equivalent or diabetes
About this study
Official title: A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.
- Conditions
- Primary Hypercholesterolemia, Mixed Hyperlipidemia
- Being tested
- niacin (+) laropiprant (+) simvastatin, Comparator: niacin (+) laropiprant, Comparator: simvastatin
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niacin (+) laropiprant (+) simvastatinDrug
Also called MK0524B
Duration of Treatment 12 Weeks
Comparator: niacin (+) laropiprantDrug
Also called MK0524A
Duration of Treatment 12 Weeks
Comparator: simvastatinDrug
Also called MK0733
Duration of Treatment 12 Weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
Secondary outcomes (2)
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,400 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
- NCT00269217
- Sponsor's protocol ID
- 0524B-022
- Other IDs
- MK0524B-022, 2005_098
- Status last verified
- Mar 2017
- First submitted
- 21 Dec 2005
- Last updated
- 7 Apr 2017
- Results posted
- No
Publications
Farnier M, Chen E, Johnson-Levonas AO, McCrary Sisk C, Mitchel YB. Effects of extended-release niacin/laropiprant, simvastatin, and the combination on correlations between apolipoprotein B, LDL cholesterol, and non-HDL cholesterol in patients with dyslipidemia. Vasc Health Risk Manag. 2014 May 7;10:279-90. doi: 10.2147/VHRM.S58694. eCollection 2014.
PubMed 24855368Ballantyne C, Gleim G, Liu N, Sisk CM, Johnson-Levonas AO, Mitchel Y. Effects of coadministered extended-release niacin/laropiprant and simvastatin on lipoprotein subclasses in patients with dyslipidemia. J Clin Lipidol. 2012 May-Jun;6(3):235-43. doi: 10.1016/j.jacl.2011.11.004. Epub 2011 Dec 3.
PubMed 22658147Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.
PubMed 22500948Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.
PubMed 21401833
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00269217
- Acronym / sponsor ID
- 0524B-022
- Conditions
- Primary Hypercholesterolemia, Mixed Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 23 Dec 2005 (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 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
- LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides </= 350 mg/dL.
Key exclusion criteria (5 listed)
- A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
- Patients with <80% compliance
- Patients with certain medical conditions
- Patients taking certain concomitant medications and/or with unstable doses of medications
- Or those with a history of CHD/CHD equivalent or diabetes
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 |
|---|---|---|
| niacin (+) laropiprant (+) simvastatinAlso: MK0524BDuration of Treatment 12 Weeks | Drug | – |
| Comparator: niacin (+) laropiprantAlso: MK0524ADuration of Treatment 12 Weeks | Drug | – |
| Comparator: simvastatinAlso: MK0733Duration of Treatment 12 Weeks | Drug | – |
Primary outcome
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
2 secondary outcomes
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.
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 7 Apr 2017.
- Derived from this study: PubMed 24855368Farnier M, Chen E, Johnson-Levonas AO, McCrary Sisk C, Mitchel YB. Effects of extended-release niacin/laropiprant, simvastatin, and the combination on correlations between apolipoprotein B, LDL cholesterol, and non-HDL cholesterol in patients with dyslipidemia. Vasc Health Risk Manag. 2014 May 7;10:279-90. doi: 10.2147/VHRM.S58694. eCollection 2014.
- Derived from this study: PubMed 22658147Ballantyne C, Gleim G, Liu N, Sisk CM, Johnson-Levonas AO, Mitchel Y. Effects of coadministered extended-release niacin/laropiprant and simvastatin on lipoprotein subclasses in patients with dyslipidemia. J Clin Lipidol. 2012 May-Jun;6(3):235-43. doi: 10.1016/j.jacl.2011.11.004. Epub 2011 Dec 3.
- Derived from this study: PubMed 22500948Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.
- Derived from this study: PubMed 21401833Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.
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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 3 study testing niacin (+) laropiprant (+) simvastatin, Comparator: niacin (+) laropiprant and Comparator: simvastatin in people with Primary Hypercholesterolemia and Mixed 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 2 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 7 Apr 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.. 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 NCT00269217, which also lists 4 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 7 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.