A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK0524B Versus Atorvastatin in Patients With Mixed Hyperlipidemia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 2,340
- Primary Endpoint
- Percentage Change From Baseline in the LDL-C/HDL-C Ratio
Study Overview
Brief Summary
This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and 190 mg/dL and Triglycerides between 150 and 500 mg/dL
Exclusion Criteria
- •Pregnant or lactating women, or women intending to become pregnant
- •Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)
- •Human immunodeficiency virus (HIV) positive
- •Any of the following within the past 3 months: heart attack, stoke, heart bypass surgery, unstable angina, angioplasty
- •Active or chronic liver disease
Arms & Interventions
MK-0524B 2g/20 mg
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Intervention: MK-0524A (Drug)
MK-0524B 2g/20 mg
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Intervention: Simvastatin (Drug)
MK-0524B 2g/40mg
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Intervention: MK-0524A (Drug)
MK-0524B 2g/40mg
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Intervention: Simvastatin (Drug)
Atorvastatin 10 mg
Atorvastatin 10 mg, orally, once daily for 12 weeks
Intervention: Atorvastatin (Drug)
Atorvastatin 20 mg
Atorvastatin 20 mg, orally, once daily for 12 weeks
Intervention: Atorvastatin (Drug)
Atorvastatin 40 mg
Atorvastatin 40 mg, orally, once daily for 12 weeks
Intervention: Atorvastatin (Drug)
Atorvastatin 80 mg
Atorvastatin 80 mg, orally, once daily for 12 weeks
Intervention: Atorvastatin (Drug)
Outcomes
Primary Outcomes
Percentage Change From Baseline in the LDL-C/HDL-C Ratio
Time Frame: Baseline and Week 12
Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.
Secondary Outcomes
- Percentage Change From Baseline in HDL-C(Baseline and Week 12)
- Percentage Change From Baseline in Triglycerides (TG)(Baseline and Week 12)
- Percentage Change From Baseline in Total Cholesterol (TC)(Baseline and Week 12)
- Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN(up to 12 weeks)
- Percentage of Participants With Creatine Kinase (CK) >=10 x ULN(up to 12 weeks)
- Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related(up to 12 weeks)
- Percentage of Participants With New Diagnosis of Diabetes(up to 12 weeks)
- Percentage Change From Baseline in Apolipoprotein (Apo) B(Baseline and Week 12)
- Percentage Change From Baseline in Non-HDL-C(Baseline and Week 12)
- Percentage Change From Baseline in LDL-C(Baseline and Week 12)
- Percentage Change From Baseline in Apo A-I(Baseline and Week 12)
- Percentage Change From Baseline in C-reactive Protein (CRP)(Baseline and Week 12)
- Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)(up to 12 weeks)
- Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE(up to 14 weeks)
- Percentage Change From Baseline in Lipoprotein (a) (Lp[a])(Baseline and Week 12)
- Percentage Change From Baseline in TC/HDL-C Ratio(Baseline and Week 12)
- Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN(up to 12 weeks)
- Percentage of Participants With CK >=10 x ULN With Muscle Symptoms(up to 12 weeks)
- Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event(up to 14 weeks)
- Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)(up to 14 weeks)
- Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE(up to 14 weeks)
- Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE(up to 14 weeks)
- Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose(up to 12 weeks)
- Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)(up to 14 weeks)