A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
- Conditions
- Hypercholesterolemia
- Interventions
- Drug: Atorvastatin calciumDrug: MK-6213Drug: Placebo for Atorvastatin 20 mgDrug: Placebo for MK-6312 160 mg
- Registration Number
- NCT00687271
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
- 18 to 75 years of age at the time of the study with high cholesterol
- Can have diabetes mellitus but is not currently on lipid lowering therapy
- Have a stable weight for >6 weeks
- Has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease
- history of mental instability or drug/alcohol abuse within the past 5 years
- Pregnant or nursing; human immunodeficiency virus (HIV) positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Atorvastatin 20 mg Atorvastatin calcium 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks MK-6213 160 mg + Atorvastatin 20 mg Atorvastatin calcium 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks MK-6213 160 mg Placebo for Atorvastatin 20 mg 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks Placebo Placebo for Atorvastatin 20 mg 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks Atorvastatin 20 mg Placebo for MK-6312 160 mg 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks MK-6213 160 mg MK-6213 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks Placebo Placebo for MK-6312 160 mg 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks MK-6213 160 mg + Atorvastatin 20 mg MK-6213 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
- Primary Outcome Measures
Name Time Method Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Baseline (predose) and Week 4 Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Experience at Least 1 Adverse Event (AE) Up to 14 days post last dose of study drug (up to 6 weeks) An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized
Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Baseline (predose) and Week 4 Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized.
Percentage of Participants That Had Study Drug Discontinued Due to an AE up to 4 weeks An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.
Percentage Change From Baseline in Apolipoprotein B (ApoB) Baseline (predose) and Week 4 Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized.
Percentage Change From Baseline in HDL-C Baseline (predose) and Week 4 Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized.
Percentage Change From Baseline in TG Baseline (predose) and Week 4 Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized.
Percentage Change From Baseline in Total Cholesterol (TC) Baseline (predose) and Week 4 Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized.