MK0859 Dose-Ranging Study - Full Text View

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.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Condition	Intervention	Phase
Hypercholesterolemia Mixed Hyperlipemia	Drug: MK0859	Phase II

Genetics Home Reference related topics: 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

Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V501 Given Concomitantly With Menactra(TM) and ADACEL(TM) in Healthy Adolescents 11-17 Years of Age

Further study details as provided by Merck:

Primary Outcome Measures:

Comparable (non-inferior) immunogenicity for all vaccine components

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

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 24, 2008
ClinicalTrials.gov Identifier:	NCT00325455
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
Healthy

Metabolic disorder
Hyperlipoproteinemia Type V
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009