search
Back to results

Lipid Efficacy/Tolerability Study (0524A-020)

Primary Purpose

Primary Hypercholesterolaemia, Mixed Hyperlipidaemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
niacin (+) laropiprant
ER-niacin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolaemia

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 with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD). Have medical conditions considered to be CHD equivalent). LDL-C below 130 mg/dL for patients with multiple risk factors. LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides </= to 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 < 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications. Pregnant or lactating women, or women intending to become pregnant are excluded. Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin). Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Reductions of LDL-C concentrations at 24 weeks and better tolerability

    Secondary Outcome Measures

    Elevations in HDL-C concentrations at 24 weeks

    Full Information

    First Posted
    December 21, 2005
    Last Updated
    July 24, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00269204
    Brief Title
    Lipid Efficacy/Tolerability Study (0524A-020)
    Official Title
    A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (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
    A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1620 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    niacin (+) laropiprant
    Other Intervention Name(s)
    MK0524A
    Intervention Description
    Duration of Treatment - 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    ER-niacin
    Intervention Description
    Duration of Treatment - 24 weeks
    Primary Outcome Measure Information:
    Title
    Reductions of LDL-C concentrations at 24 weeks and better tolerability
    Time Frame
    at 24 weeks
    Secondary Outcome Measure Information:
    Title
    Elevations in HDL-C concentrations at 24 weeks
    Time Frame
    at 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD). Have medical conditions considered to be CHD equivalent). LDL-C below 130 mg/dL for patients with multiple risk factors. LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides </= to 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 < 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications. Pregnant or lactating women, or women intending to become pregnant are excluded. Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin). Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).
    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
    17087947
    Citation
    Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A, Bolognese JA, Oxenius B, Horgan K, Loftus S, Morton DG; APPROVe Trial Investigators. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec;131(6):1674-82. doi: 10.1053/j.gastro.2006.08.079. Epub 2006 Sep 1.
    Results Reference
    background
    PubMed Identifier
    19166443
    Citation
    Maccubbin D, Bays HE, Olsson AG, Elinoff V, Elis A, Mitchel Y, Sirah W, Betteridge A, Reyes R, Yu Q, Kuznetsova O, Sisk CM, Pasternak RC, Paolini JF. Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2008 Dec;62(12):1959-70. doi: 10.1111/j.1742-1241.2008.01938.x.
    Results Reference
    background
    PubMed Identifier
    19243712
    Citation
    Bays HE, Maccubbin D, Meehan AG, Kuznetsova O, Mitchel YB, Paolini JF. Blood pressure-lowering effects of extended-release niacin alone and extended-release niacin/laropiprant combination: a post hoc analysis of a 24-week, placebo-controlled trial in dyslipidemic patients. Clin Ther. 2009 Jan;31(1):115-22. doi: 10.1016/j.clinthera.2009.01.010.
    Results Reference
    background
    PubMed Identifier
    24854458
    Citation
    Rao M, Steffes M, Bostom A, Ix JH. Effect of niacin on FGF23 concentration in chronic kidney disease. Am J Nephrol. 2014;39(6):484-90. doi: 10.1159/000362424. Epub 2014 May 20.
    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

    Learn more about this trial

    Lipid Efficacy/Tolerability Study (0524A-020)

    We'll reach out to this number within 24 hrs