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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00286481 | Efficacy of Lapaquistat Acetate Alone or Combined With Simvastatin in Subjects With Hypercholesterolemia | PHASE3 | COMPLETED | 1,362 | — | — | Mar 1, 2006 | May 1, 2007 | May 24, 2012 | 67 | United States, Canada |
| NCT00868127 | Safety of Lapaquistat Acetate in Subjects With Hypercholesterolemia | PHASE3 | COMPLETED | 574 | — | — | Dec 1, 2005 | Jul 1, 2007 | May 24, 2012 | - | — |
| NCT00249912 | Efficacy of Lapaquistat Acetate Alone or Combined With Rosuvastatin in Subjects With Hypercholesterolemia | PHASE3 | COMPLETED | 415 | — | — | Oct 1, 2005 | Apr 1, 2007 | May 24, 2012 | 92 | United States, Canada |
| NCT00256178 | Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia. | PHASE3 | COMPLETED | 411 | — | — | Oct 1, 2005 | Mar 1, 2007 | May 24, 2012 | 53 | Czechia, Estonia +5 |
| NCT00268697 | Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia. | PHASE3 | COMPLETED | 1,267 | — | — | Oct 1, 2005 | Jan 1, 2007 | May 24, 2012 | 9 | Estonia, Latvia +2 |
| NCT00143676 | Efficacy of Lapaquistat Acetate and Atorvastatin on Blood Cholesterol Levels in Subjects With Primary Hypercholesterolemia | PHASE3 | COMPLETED | 448 | — | — | Aug 1, 2005 | Aug 1, 2006 | May 24, 2012 | 78 | United States |
| NCT00864643 | Efficacy and Safety of Lapaquistat Acetate Coadministered With Atorvastatin in Subjects With Hypercholesterolemia | PHASE2 | COMPLETED | 172 | — | — | Sep 1, 2004 | Feb 1, 2005 | May 24, 2012 | - | — |
| Arm | Type | Description |
|---|---|---|
| Lapaquistat Acetate 50 mg QD + Simvastatin | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Simvastatin | EXPERIMENTAL | - |
| Simvastatin | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Added Therapy | EXPERIMENTAL | - |
| Lapaquistat Acetate 50 mg QD + Rosuvastatin | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Rosuvastatin | EXPERIMENTAL | - |
| Rosuvastatin | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD + Ezetimibe | EXPERIMENTAL | - |
| Ezetimibe | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 50 mg QD + Atorvastatin | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Atorvastatin | EXPERIMENTAL | - |
| Atorvastatin | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD + Atorvastatin QD | EXPERIMENTAL | - |
| Atorvastatin QD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Lapaquistat acetate and simvastatin | DRUG | Lapaquistat acetate 50 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks. |
| Simvastatin | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks. |
| Lapaquistat acetate | DRUG | Participants from 01-04-TL-475-008 Monotherapy Study: Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 48 weeks. |
| Lapaquistat acetate and additional lipid-lowering therapy | DRUG | Participants from 01-04-TL-475-009 Atorvastatin Add-on Study: Lapaquistat acetate 100 mg, tablets, orally, once daily and current Atorvastatin therapy for up to 4 weeks. Then, Lapaquistat 100 mg, tablets, orally, once daily and dose adjustment of Atorvastatin OR additional companion lipid-lowering therapy as needed for target LDL-C for up to 42 weeks. |
| Lapaquistat acetate and rosuvastatin | DRUG | Lapaquistat acetate 50 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks. |
| Rosuvastatin | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks. |
| Lapaquistat acetate and ezetimibe | DRUG | Lapaquistat acetate 100 mg, tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks. |
| Ezetimibe | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks. |
| Lapaquistat acetate and atorvastatin | DRUG | Lapaquistat acetate 50 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks. |
| Atorvastatin | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks. |
Inclusion Criteria: * Woman of childbearing potential can not to be pregnant, lactating, not planning on becoming pregnant, and agree to use acceptable forms of contraception throughout the course of the study. * Prior to Randomization, has a low-density lipoprotein cholesterol level mean greater t...