Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00687271 | A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006) | PHASE2 | COMPLETED | 334 | — | — | Jun 14, 2008 | Jan 8, 2009 | Jan 14, 2019 | - | — |
Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.
| Arm | Type | Description |
|---|---|---|
| MK-6213 160 mg + Atorvastatin 20 mg | EXPERIMENTAL | 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks |
| Atorvastatin 20 mg | ACTIVE_COMPARATOR | 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks |
| MK-6213 160 mg | EXPERIMENTAL | 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks |
| Placebo | PLACEBO_COMPARATOR | 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks |
| Name | Type | Description |
|---|---|---|
| MK-6213 | DRUG | MK-6213 160 mg for 4 weeks. |
| Atorvastatin calcium | DRUG | atorvastatin calcium 20mg for 4 weeks. |
| Placebo for MK-6312 160 mg | DRUG | - |
| Placebo for Atorvastatin 20 mg | DRUG | - |
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 (ner...