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
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: 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 July 28, 2014