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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01760460 | A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1) | PHASE3 | COMPLETED | 307 | — | — | Mar 14, 2013 | Mar 4, 2015 | Jun 1, 2017 | - | — |
| NCT00977288 | A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029) | PHASE2 | COMPLETED | 408 | — | — | Sep 1, 2009 | Apr 1, 2014 | May 6, 2015 | - | — |
| NCT01122667 | Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038) | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2010 | Jun 1, 2011 | Aug 14, 2015 | - | — |
| NCT01114490 | Pharmacokinetics of Anacetrapib (MK0859) in Patients With Hepatic Insufficiency (MK-0859-039) | PHASE1 | COMPLETED | 24 | — | — | May 1, 2010 | Jul 1, 2010 | Oct 14, 2015 | - | — |
| NCT00990808 | The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3) | PHASE1 | COMPLETED | 46 | — | — | Nov 1, 2009 | Jul 1, 2011 | Jun 4, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Anacetrapib | EXPERIMENTAL | Participants will receive 100-mg anacetrapib, orally, once-daily for 24 weeks. Participants will continue on once-daily 100-mg anacetrapib during 28 week open-label extension. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo tablet, orally, once daily for 24 weeks. Participants will be switched to once-daily 100-mg anacetrapib during 28 week open-label extension. |
| 1 | EXPERIMENTAL | MK0859 10 mg + placebo |
| 2 | EXPERIMENTAL | MK0859 40 mg + placebo |
| 3 | EXPERIMENTAL | MK0859 100 mg + placebo |
| 4 | EXPERIMENTAL | MK0859 300 mg + placebo |
| 5 | EXPERIMENTAL | MK0859 10 mg + atorvastatin 10mg |
| 6 | EXPERIMENTAL | MK0859 40 mg + atorvastatin 10mg |
| 7 | EXPERIMENTAL | MK0859 100 mg + atorvastatin 10mg |
| 8 | EXPERIMENTAL | MK0859 300 mg + atorvastatin 10mg |
| 9 | PLACEBO_COMPARATOR | Placebo + atorvastatin 10mg |
| 10 | PLACEBO_COMPARATOR | Placebo |
| Part 1 - Panel A | EXPERIMENTAL | Subjects with severe renal impairment |
| Part 1 - Panel B | EXPERIMENTAL | Healthy matched control subjects |
| Part 2 - Panel C | EXPERIMENTAL | Subjects with moderate renal impairment |
| Part 2 - Panel D | EXPERIMENTAL | Healthy matched control subjects |
| Part 2 - Panel E | EXPERIMENTAL | Subjects with mild renal impairment |
| Part 2 - Panel F | EXPERIMENTAL | Healthy matched control subjects |
| Part 1 - Group 1 | EXPERIMENTAL | Moderate Hepatic Patients |
| Part 1 - Group 2 | EXPERIMENTAL | Healthy Subjects |
| Part 2 - Group 1 | EXPERIMENTAL | Mild Hepatic Patients |
| Part 2 - Group 2 | EXPERIMENTAL | Healthy Subjects |
| Panel A | EXPERIMENTAL | Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859 |
| Panel B | EXPERIMENTAL | Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin |
| Name | Type | Description |
|---|---|---|
| Anacetrapib | DRUG | - |
| Placebo for anacetrapib | DRUG | - |
| Comparator: atorvastatin | DRUG | atorvastatin tablet, 10mg, once daily for 8 weeks |
| Comparator: Placebo | DRUG | Placebo tablet, once daily for 8 weeks |
| Comparator: placebo to MK0859 | DRUG | Placebo to MK0859 once daily for 4 weeks. |
| Comparator: placebo to atorvastatin | DRUG | Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2. |
Inclusion Criteria: * If female, cannot be of reproductive potential * Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines Exclusion Criteria: * Pr...