A Phase 2 interventional study of anacetrapib and Comparator: atorvastatin in Dyslipidemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-06.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.
This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients.
Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period.
As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 408 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,111 studies on the registry; 130 are open to participants now.
Of its 488 completed or terminated interventional studies of FDA-regulated products, 361 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MK0859 10 mg + placebo
Drug: anacetrapib · Drug: Comparator: Placebo
MK0859 40 mg + placebo
Drug: anacetrapib · Drug: Comparator: Placebo
MK0859 100 mg + placebo
Drug: anacetrapib · Drug: Comparator: Placebo
MK0859 300 mg + placebo
Drug: anacetrapib · Drug: Comparator: Placebo
MK0859 10 mg + atorvastatin 10mg
Drug: anacetrapib · Drug: Comparator: atorvastatin
MK0859 40 mg + atorvastatin 10mg
Drug: anacetrapib · Drug: Comparator: atorvastatin
MK0859 100 mg + atorvastatin 10mg
Drug: anacetrapib · Drug: Comparator: atorvastatin
MK0859 300 mg + atorvastatin 10mg
Drug: anacetrapib · Drug: Comparator: atorvastatin
Placebo + atorvastatin 10mg
Drug: Comparator: atorvastatin · Drug: Comparator: Placebo
Placebo
Drug: Comparator: Placebo
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Also known as: MK0859
atorvastatin tablet, 10mg, once daily for 8 weeks
Placebo tablet, once daily for 8 weeks
The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
Time frame: 8 weeks
The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8
Time frame: 8 weeks
No study locations are listed for this record.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC