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: September 12, 2014
Last verified: September 2014

October 6, 2009
September 12, 2014
November 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00990808 on ClinicalTrials.gov Archive Site
Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dyslipidemia
  • 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.
  • Drug: Comparator: placebo to atorvastatin
    Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
  • Experimental: Panel A
    Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
    Interventions:
    • Drug: anacetrapib
    • Drug: Comparator: atorvastatin
    • Drug: Comparator: placebo to MK0859
  • Experimental: Panel B
    Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin
    Interventions:
    • Drug: anacetrapib
    • Drug: Comparator: placebo to MK0859
    • Drug: Comparator: placebo to atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00990808
0859-026, 0859-026
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP