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Completed

NCT Number: NCT00990808

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

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

Completed

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anacetrapib

Drug

[Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.

Comparator: atorvastatin

Drug

Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

Comparator: placebo to MK0859

Drug

Placebo to MK0859 once daily for 4 weeks.

Comparator: placebo to atorvastatin

Drug

Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

Primary outcomes

  1. 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

Secondary outcomes

  1. Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2009
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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