MK0524B Lipid Study (0524B-063)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00479882
First received: May 24, 2007
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This is a 20-week clinical trial in patients with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK0524B compared to MK0524A + Simvastatin on lipid values.


Condition Intervention Phase
Primary Hypercholesterolemia
Mixed Dyslipidemia
Drug: MK0524B
Drug: niacin (+) laropiprant
Drug: Comparator: simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, "Crossover" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Lipid values at the end of each crossover period compared to baseline [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety/Tolerability [ Time Frame: 20 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2370
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
MK0524B 0.9 g/40 mg, crossing to a co-administration arm in week 12
Drug: MK0524B
MK0524B 0.9 g/40 mg; MK0524B 0.9 g/10 mg, Study period will run approximately 12 weeks.
2
niacin (+) laropiprant 1 g + simvastatin 40 mg, crossing to an MK0524B arm in week 12
Drug: niacin (+) laropiprant
niacin (+) laropiprant 1 g; Study period will run approximately 12 weeks.
Other Names:
  • MK0524A
  • CORDAPTIVE™
Drug: Comparator: simvastatin
simvastatin 40 mg, Study period will run approximately 12 weeks.
Other Names:
  • Zocor®
  • MK0733
3
MK0524B 0.9 g/10 mg, crossing to a co-administration arm in week 12
Drug: MK0524B
MK0524B 0.9 g/40 mg; MK0524B 0.9 g/10 mg, Study period will run approximately 12 weeks.
4
niacin (+) laropiprant 1 g + simvastatin 10 mg, crossing to an MK0524B arm in week 12
Drug: niacin (+) laropiprant
niacin (+) laropiprant 1 g; Study period will run approximately 12 weeks.
Other Names:
  • MK0524A
  • CORDAPTIVE™
Drug: Comparator: simvastatin
simvastatin 40 mg, Study period will run approximately 12 weeks.
Other Names:
  • Zocor®
  • MK0733

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit
  • Patient meets one of the following triglyceride (TG) criteria:

    1. Patient is on niacin, statin, or fibrate and has TG <500 mg/dL at or within 6 months of washout
    2. Patient is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG <600 mg/dL at or within 6 months of screening

Exclusion Criteria:

  • Patient is high risk (CHD or CHD risk equivalent) AND is on a statin
  • Patient is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
  • Patient with Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
  • Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479882

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00479882     History of Changes
Other Study ID Numbers: 0524B-063, MK0524B-063, 2007_504
Study First Received: May 24, 2007
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Simvastatin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014