NCT00269217

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

December 21, 2005

Last Update Submit

April 5, 2017

Conditions

Primary HypercholesterolemiaMixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

niacin (+) laropiprant (+) simvastatinDRUG

Duration of Treatment 12 Weeks

Also known as: MK0524B
Comparator: niacin (+) laropiprantDRUG

Duration of Treatment 12 Weeks

Also known as: MK0524A
Comparator: simvastatinDRUG

Duration of Treatment 12 Weeks

Also known as: MK0733

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 24855368DERIVED

  • Ballantyne 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.

    PMID: 22658147DERIVED

  • Bays 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.

    PMID: 22500948DERIVED

  • Bays 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.

    PMID: 21401833DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

NiacinMK-0524Simvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 7, 2017

Record last verified: 2017-03