MK0859 Dose-Ranging Study (0859-003)
This study has been terminated.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00325455
First received: May 11, 2006
Last updated: April 1, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| 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: | MK0859 Dose-Ranging Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
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: | March 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
More Information
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00325455 History of Changes |
| Other Study ID Numbers: | 2006_006, MK0859-003 |
| Study First Received: | May 11, 2006 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type V Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias Hypertriglyceridemia |
ClinicalTrials.gov processed this record on May 23, 2013