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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00990808
First received: October 6, 2009
Last updated: July 24, 2013
Last verified: July 2013
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 46
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990808

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00990808     History of Changes
Other Study ID Numbers: 2009_665, 0859-026
Study First Received: October 6, 2009
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014