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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014