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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00977288
Other study ID # 0859-029
Secondary ID 2009_662
Status Completed
Phase Phase 2
First received September 14, 2009
Last updated May 5, 2015
Start date September 2009
Est. completion date April 2014

Study information

Verified date May 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 408
Est. completion date April 2014
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia

Exclusion Criteria:

- Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)

- Patients has uncontrolled diabetes

- Patient is currently participating or has participated in a study with an investigational compound within the last 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Comparator: Placebo
Placebo tablet, once daily for 8 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Teramoto T, Shirakawa M, Kikuchi M, Nakagomi M, Tamura S, Surks HK, McCrary Sisk C, Numaguchi H. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia. Atherosclerosis. 2013 Sep;230(1):5 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8 8 weeks No
Secondary 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 8 weeks No
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