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The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00990808
First received: October 6, 2009
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
  Purpose

This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.


Condition Intervention Phase
Dyslipidemia
 Drug: anacetrapib
Drug: Comparator: atorvastatin
Drug: Comparator: placebo to MK0859
Drug: Comparator: placebo to atorvastatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A
Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
 Drug: anacetrapib
[Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.
Drug: Comparator: atorvastatin
Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
Drug: Comparator: placebo to MK0859
Placebo to MK0859 once daily for 4 weeks.
Experimental: Panel B
Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin
 Drug: anacetrapib
[Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.
Drug: Comparator: placebo to MK0859
Placebo to MK0859 once daily for 4 weeks.
Drug: Comparator: placebo to atorvastatin
Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's weight has been stable for at least 6 weeks
  • Patient is in good health based on medical history, physical exam, and laboratory tests
  • Patient has dyslipidemia

Exclusion Criteria :

  • Patient has a history of stroke, seizures, or major neurological disorders
  • Patient has a history of cancer
  • Patient is currently taking any lipid-lowering medications or substances except for statins
  • Patient consumes excessive amounts of alcohol or caffeine
  • Patient has multiple and/or severe allergies to food or drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990808

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

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00990808     History of Changes
Other Study ID Numbers: 2009_665, MK0859-026
Study First Received: October 6, 2009
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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