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Lipid Efficacy Study (0524B-022)(COMPLETED)

Primary Purpose

Primary Hypercholesterolemia, Mixed Hyperlipidemia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

niacin (+) laropiprant (+) simvastatin

Comparator: niacin (+) laropiprant

Comparator: simvastatin

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

Outcomes

Primary Outcome Measures

Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00269217

First Posted

December 21, 2005

Last Updated

April 5, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00269217

Brief Title

Lipid Efficacy Study (0524B-022)(COMPLETED)

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hypercholesterolemia, Mixed Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1400 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

niacin (+) laropiprant (+) simvastatin

Other Intervention Name(s)

MK0524B

Intervention Description

Duration of Treatment 12 Weeks

Intervention Type

Drug

Intervention Name(s)

Comparator: niacin (+) laropiprant

Other Intervention Name(s)

MK0524A

Intervention Description

Duration of Treatment 12 Weeks

Intervention Type

Drug

Intervention Name(s)

Comparator: simvastatin

Other Intervention Name(s)

MK0733

Intervention Description

Duration of Treatment 12 Weeks

Primary Outcome Measure Information:

Title

Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Secondary Outcome Measure Information:

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

24855368

Citation

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.

Results Reference

derived

PubMed Identifier

22658147

Citation

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.

Results Reference

derived

PubMed Identifier

22500948

Citation

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.

Results Reference

derived

PubMed Identifier

21401833

Citation

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.

Results Reference

derived

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis Link

Available IPD/Information URL

http://www.merck.com/clinical-trials/policies-perspectives.html

Learn more about this trial

Lipid Efficacy Study (0524B-022)(COMPLETED)

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