Lipid Efficacy and Safety in Patients With Mixed Hyperlipidemia (MK-0524B-024)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00289900
First received: February 7, 2006
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This is a 12-week clinical trial in patients with mixed hyperlipidemia to study the effects of MK0524B on lipids.


Condition Intervention Phase
Mixed Hyperlipidemia
Drug: Comparator: MK0524B
Drug: Comparator: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK0524B Versus Atorvastatin in Patients With Mixed Hyperlipidemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in LDL-C/HDL-C ratio [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in other lipid parameters [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 2355
Study Start Date: January 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
drug; MK0524B 2g/20 mg (MK0524B 1g/10 mg x 4 wk, then 2g/20 mg x 8wk)
Drug: Comparator: MK0524B
MK0524B 2g/20 mg (MK0524B 1g/10 mg x 4 wk, then 2g/20 mg x 8wk); MK0524B 2g/40 mg (MK0524B 1g/20 mg x 4 wk, then 2g/40 mg x 8wk); for a 20 week study period
Experimental: Arm 2
drug; MK0524B 2g/40 mg (MK0524B 1g/20 mg x 4 wk, then 2g/40 mg x 8wk)
Drug: Comparator: MK0524B
MK0524B 2g/20 mg (MK0524B 1g/10 mg x 4 wk, then 2g/20 mg x 8wk); MK0524B 2g/40 mg (MK0524B 1g/20 mg x 4 wk, then 2g/40 mg x 8wk); for a 20 week study period
Active Comparator: Arm 3
active comparator; Atorvastatin 10 mg
Drug: Comparator: Atorvastatin
Atorvastatin 10 mg; Atorvastatin 20 mg; Atorvastatin 40 mg; Atorvastatin 80 mg for a 20 week study period
Active Comparator: Arm 4
active comparator; Atorvastatin 20 mg
Drug: Comparator: Atorvastatin
Atorvastatin 10 mg; Atorvastatin 20 mg; Atorvastatin 40 mg; Atorvastatin 80 mg for a 20 week study period
Active Comparator: Arm 5
active comparator; Atorvastatin 40 mg
Drug: Comparator: Atorvastatin
Atorvastatin 10 mg; Atorvastatin 20 mg; Atorvastatin 40 mg; Atorvastatin 80 mg for a 20 week study period
Active Comparator: Arm 6
active comparator; Atorvastatin 80 mg
Drug: Comparator: Atorvastatin
Atorvastatin 10 mg; Atorvastatin 20 mg; Atorvastatin 40 mg; Atorvastatin 80 mg for a 20 week study period

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and 190 mg/dL and Triglycerides between 150 and 500 mg/dL

Exclusion Criteria:

  • Pregnant or lactating women, or women intending to become pregnant
  • Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)
  • HIV positive
  • Any of the following within the past 3 months: heart attack, stoke, heart bypass surgery, unstable angina, angioplasty
  • Active or chronic liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289900

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289900     History of Changes
Other Study ID Numbers: 0524B-024, MK0524B-024, 2005_103
Study First Received: February 7, 2006
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014