Phase 3 N=2,340 Randomized Double-blind Treatment

Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

Mixed Hyperlipidemia

Bottom Line

View on ClinicalTrials.gov: NCT00289900 ↗

Enrolled (actual)

2,340

Serious AEs

1.2%

Results posted

Jan 2016

Primary outcome: Primary: Percentage Change From Baseline in the LDL-C/HDL-C Ratio — -50.9; -53.0; -37.6; -42.4 Percentage Change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MK-0524A (Drug); Atorvastatin (Drug); Simvastatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change From Baseline in the LDL-C/HDL-C Ratio	-50.9; -53.0; -37.6; -42.4; -47.9; -48.8	<0.001 sig
SECONDARY Percentage Change From Baseline in HDL-C	26.9; 26.6; 7.0; 5.3; 4.5; 3.6	<0.001 sig
SECONDARY Percentage Change From Baseline in Triglycerides (TG)	-40.3; -42.0; -21.9; -23.8; -30.4; -33.8	<0.001 sig
SECONDARY Percentage Change From Baseline in Non-HDL-C	-40.4; -42.2; -31.3; -36.8; -42.6; -44.6	<0.001 sig
SECONDARY Percentage Change From Baseline in LDL-C	-40.4; -42.8; -33.6; -39.8; -45.6; -47.5	<0.001 sig
SECONDARY Percentage Change From Baseline in Apolipoprotein (Apo) B	-36.1; -38.0; -26.9; -32.8; -37.2; -38.3	<0.001 sig
SECONDARY Percentage Change From Baseline in Apo A-I	10.7; 8.2; 1.7; 0.4; -0.8; -2.5	<0.001 sig
SECONDARY Percentage Change From Baseline in Total Cholesterol (TC)	-28.1; -30.0; -24.6; -29.4; -34.2; -36.1	0.003 sig
SECONDARY Percentage Change From Baseline in Lipoprotein (a) (Lp[a])	-15.2; -14.6; 0.0; 0.0; 7.8; 8.8	<0.001 sig
SECONDARY Percentage Change From Baseline in C-reactive Protein (CRP)	-15.4; -20.0; -19.5; -28.6; -33.3; -38.1	0.500
SECONDARY Percentage Change From Baseline in TC/HDL-C Ratio	-41.0; -42.3; -28.2; -31.5; -36.0; -36.7	<0.001 sig
SECONDARY Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)	0.4; 1.8	0.008 sig
SECONDARY Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN	0.1; 0.9	0.042 sig
SECONDARY Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN	0.0; 0.1	0.346
SECONDARY Percentage of Participants With Creatine Kinase (CK) >=10 x ULN	0.1; 0.1	0.556
SECONDARY Percentage of Participants With CK >=10 x ULN With Muscle Symptoms	0.1; 0.0	0.134
SECONDARY Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related	0.1; 0.0	0.134
SECONDARY Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose	0.2; 0.1	0.5625
SECONDARY Percentage of Participants With New Diagnosis of Diabetes	0.9; 0.2	0.0233 sig
SECONDARY Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event	0.1; 0.2	0.7858
SECONDARY Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)	59.6; 45.9	—
SECONDARY Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)	5.2; 5.9	—
SECONDARY Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE	16.5; 4.9	—
SECONDARY Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE	0.7; 0.7	—
SECONDARY Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE	0.0; 0.1	0.4997

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00289900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.