Phase 2
Completed N=334
A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
Source: ClinicalTrials.gov NCT00687271 ↗Enrolled (actual)
334
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -50.7; -40.6; -13.3; 4.6 Percentage Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) |
-50.7; -40.6; -13.3; 4.6 | — |
| SECONDARY Percentage of Participants Who Experience at Least 1 Adverse Event (AE) |
33.0; 37.9; 29.2; 41.7 | — |
| SECONDARY Percentage of Participants That Had Study Drug Discontinued Due to an AE |
1.1; 3.1; 1.0; 0.0 | — |
| SECONDARY Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) |
-46.6; -38.0; -11.4; 2.5 | — |
| SECONDARY Percentage Change From Baseline in Apolipoprotein B (ApoB) |
-40.4; -32.7; -8.8; 3.5 | — |
| SECONDARY Percentage Change From Baseline in Total Cholesterol (TC) |
-35.1; -27.6; -8.5; 2.5 | — |
| SECONDARY Percentage Change From Baseline in HDL-C |
3.8; 6.2; 1.4; 2.1 | — |
| SECONDARY Percentage Change From Baseline in TG |
-24.2; -25.9; 1.6; -7.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00687271). 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. Informational only — not medical advice.