A Study of MK6213 Co-Administered With Atorvastatin in Patients With Hypercholesterolemia
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00687271
First received: May 27, 2008
Last updated: February 5, 2009
Last verified: February 2009
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Purpose
The purpose of this study is to test the safety and effectiveness of MK6213 as compared to MK6213/Atorvastatin in patients (18 to 75 years) with high cholesterol.
| Condition | Intervention | Phase |
|---|---|---|
|
High Cholesterol |
Drug: MK6213 Drug: Comparator: atorvastatin calcium Drug: Comparator: placebo (unspecified) |
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: | A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy, and Tolerability of MK6213 Co-Administered With Atorvastatin in Patients With Primary Hypercholesterolemia |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Evaluate the efficacy of MK6213 co-administered with atorvastatin compared to atorvastatin monotherapy in lowering LDL-C [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the safety and tolerability of MK6213 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 330 |
| Study Start Date: | June 2008 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MK6213 160mg
|
Drug: MK6213
MK6213 160mg for 4 weeks.
Other Name: MK6213
|
|
Experimental: 2
MK6213 160mg + atorvastatin 20mg
|
Drug: MK6213
MK6213 160mg for 4 weeks.
Other Name: MK6213
Drug: Comparator: atorvastatin calcium
atorvastatin calcium 20mg for 4 weeks.
Other Names:
|
|
Active Comparator: 3
atorvastatin 20mg
|
Drug: Comparator: atorvastatin calcium
atorvastatin calcium 20mg for 4 weeks.
Other Names:
|
|
Placebo Comparator: 4
Placebo
|
Drug: Comparator: placebo (unspecified)
Duration of Treatment: 4 Weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is 18 to 75 years of age at the time of the study with high cholesterol
- can have diabetes mellitus but is not currently on lipid lowering therapy
- have a stable weight for >6 weeks
Exclusion Criteria:
- Patient has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease
- history of mental instability or drug/alcohol abuse within the past 5 years
- pregnant or nursing; HIV positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00687271 History of Changes |
| Other Study ID Numbers: | 2007_514, MK6213-006 |
| Study First Received: | May 27, 2008 |
| Last Updated: | February 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases 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 May 22, 2013