Clinical trial NCT00289900: Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mixed Hyperlipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 2340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change From Baseline in the LDL-C/HDL-C Ratio
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage Change From Baseline in HDL-C
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in Triglycerides (TG)
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in Non-HDL-C
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in LDL-C
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in Apolipoprotein (Apo) B
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in Apo A-I
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in Total Cholesterol (TC)
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in Lipoprotein (a) (Lp[a])
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in C-reactive Protein (CRP)
timeFrame: Baseline and Week 12
measure: Percentage Change From Baseline in TC/HDL-C Ratio
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
timeFrame: up to 12 weeks
measure: Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN
timeFrame: up to 12 weeks
measure: Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN
timeFrame: up to 12 weeks
measure: Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
timeFrame: up to 12 weeks
measure: Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
timeFrame: up to 12 weeks
measure: Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
timeFrame: up to 12 weeks
measure: Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
timeFrame: up to 12 weeks
measure: Percentage of Participants With New Diagnosis of Diabetes
timeFrame: up to 12 weeks
measure: Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
timeFrame: up to 14 weeks
measure: Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
timeFrame: up to 14 weeks
measure: Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)
timeFrame: up to 14 weeks
measure: Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
timeFrame: up to 14 weeks
measure: Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
timeFrame: up to 14 weeks
measure: Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE
timeFrame: up to 14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chen F, Maccubbin D, Yan L, Sirah W, Chen E, Sisk CM, Davidson M, Blomqvist P, McKenney JM. Lipid-altering efficacy and safety profile of co-administered extended release niacin/laropiprant and simvastatin versus atorvastatin in patients with mixed hyperlipidemia. Int J Cardiol. 2013 Jul 15;167(1):225-31. doi: 10.1016/j.ijcard.2011.12.103. Epub 2012 Feb 4.