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MK-6213 Efficacy and Tolerability Study in Primary Hypercholesterolemia
NCT00687271Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2008
- Primary completion
- Jan 2009
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- MK-6213
- Conditions
- hypercholesterolemia
01
Overview
Phase 2, randomised, double-blind trial of MK-6213 in hypercholesterolemia (4 arms), sponsored by Merck & Co. Primary endpoint: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol at 4 weeks. Started Jun 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
MK-6213 + Atorvastatin
MK-6213 160 mg + Atorvastatin 20 mg
Atorvastatin
Atorvastatin 20 mg + Placebo
MK-6213
MK-6213 160 mg + Placebo
Placebo
Placebo + Placebo
03
Who it enrols
Adults 18-75 with high cholesterol, stable weight, no significant CV/renal/hepatic disease, no recent cancer or substance abuse.
04
Endpoints
Primary
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol
Secondary
Percentage of Participants Who Experience at Least 1 Adverse Event
Percentage of Participants That Had Study Drug Discontinued Due to an AE
Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol
Percentage Change From Baseline in Apolipoprotein B
Percentage Change From Baseline in Total Cholesterol
Percentage Change From Baseline in HDL-C
Percentage Change From Baseline in Triglycerides
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