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MK0859 Dose-Ranging Study
This study has been completed.
First Received: May 11, 2006   Last Updated: April 13, 2009   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00325455
  Purpose

To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.


Condition Intervention Phase
Hypercholesterolemia
Mixed Hyperlipemia
 Drug: MK0859
 Phase II

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency
MedlinePlus related topics: Cholesterol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: MK0859 Dose-Ranging Study

Further study details as provided by Merck:

Primary Outcome Measures:
  • To assess the cholesterol changing effects of MK0859

Secondary Outcome Measures:
  • Acceptable safety profile

Enrollment: 500
Study Start Date: June 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol

Exclusion Criteria:

  • Patients with CHD or CHD-equivalent disease (except diabetes)
  • Diabetics on statins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325455

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:
Bloomfield D, Carlson GL, Sapre A, Tribble D, McKenney JM, Littlejohn TW 3rd, Sisk CM, Mitchel Y, Pasternak RC. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib as monotherapy and coadministered with atorvastatin in dyslipidemic patients. Am Heart J. 2009 Feb;157(2):352-360.e2. Epub 2008 Dec 20.

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2006_006, MK0859-003
Study First Received: May 11, 2006
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00325455     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Hyperlipidemias
Genetic Diseases, Inborn
Hyperlipoproteinemia Type V
 Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Hyperlipidemias
Genetic Diseases, Inborn
 Hyperlipoproteinemia Type V
Hypercholesterolemia
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009



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