Phase 3
N=2,414
MK-0524B Lipid Study (MK-0524B-063)
Primary Hypercholesterolemia · Mixed Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00479882 ↗Enrolled (actual)
2,414
Serious AEs
1.0%
Results posted
Apr 2016
Primary outcome: Primary: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -44.6; -46.9; -48.9; -50.4 Percentage Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: simvastatin (Drug); MK-0524A (Drug); Placebo (Drug); MK-0524B (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) |
-44.6; -46.9; -48.9; -50.4 | — |
| SECONDARY Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) |
27.4; 27.6; 27.7; 28.5 | — |
| SECONDARY Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) |
0.3; 0.5; 0.6; 0.9; 0.7; 1.0 | 0.685 |
| SECONDARY Percentage of Participants With Creatine Kinase (CK) >=10 x ULN |
0.0; 0.0; 0.4; 0.0; 0.4; 0.2 | 0.617 |
| SECONDARY Percentage of Participants With CK >=10 x ULN With Muscle Symptoms |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose |
0.0; 0.2; 0.0; 0.0; 0.0; 0.0 | 0.497 |
| SECONDARY Percentage of Participants With New Diagnosis of Diabetes |
0.4; 0.7; 0.5; 0.7; 0.6; 0.4 | 0.449 |
| SECONDARY Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline |
1.8; 15.7; 4.4; 8.3; 3.8; 8.3 | 0.020 sig |
| SECONDARY Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event |
0.0; 0.0; 0.2; 0.0; 0.2; 0.0 | — |
| SECONDARY Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE) |
67.5; 68.9; 35.6; 37.5; 67.5; 67.4 | — |
| SECONDARY Percentage of Participants Who Experience at Least 1 Laboratory AE |
3.9; 4.2; 5.9; 3.6; 6.2; 4.6 | — |
| SECONDARY Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE |
15.9; 15.9; 1.9; 2.7; 16.4; 14.4 | — |
| SECONDARY Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE |
0.0; 0.7; 0.6; 0.2; 0.7; 0.8 | — |
| SECONDARY Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE |
0.2; 0.0; 0.0; 0.0; 0.0; 0.2 | — |
| SECONDARY Percentage Change From Baseline in LDL-C at Week 4 |
-34.8; -35.8; -42.2; -45.8 | 0.341 |
| SECONDARY Percentage Change From Baseline in HDL-C at Week 4 |
18.3; 18.7; 19.8; 19.6 | 0.690 |
Summary
This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.
Eligibility Criteria
Inclusion Criteria
- has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit
- meets one of the following triglyceride (TG) criteria:
- is on niacin, statin, or fibrate and has TG <500 mg/dL at or within 6 months of washout
- is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG <600 mg/dL at or within 6 months of screening
Exclusion Criteria
- is high risk (coronary heart disease [CHD] or CHD risk equivalent) AND is on a statin
- is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
- has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
- has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)
Data sourced from ClinicalTrials.gov (NCT00479882). 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.