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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00143663 | Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol | PHASE3 | COMPLETED | 361 | — | — | Sep 1, 2005 | Apr 1, 2006 | May 24, 2012 | 47 | United States |
| NCT00487994 | Safety and Efficacy of Lapaquistat Acetate Taken Alone and With Atorvastatin in Subjects With Primary Dyslipidemia | PHASE3 | COMPLETED | 2,130 | — | — | Nov 1, 2004 | May 1, 2007 | May 24, 2012 | 128 | United States, Argentina +15 |
| Arm | Type | Description |
|---|---|---|
| Lapaquistat Acetate 100 mg QD | EXPERIMENTAL | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD + Atorvastatin 10 mg QD | EXPERIMENTAL | - |
| Atorvastatin 10 mg QD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Lapaquistat Acetate | DRUG | Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 12 weeks |
| Placebo | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks |
| Lapaquistat acetate and atorvastatin | DRUG | Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks. |
| Atorvastatin | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks. |
Inclusion Criteria: * Female participants of childbearing potential cannot be been pregnant, lactating and are not planning on becoming pregnant and agrees to use acceptable forms of contraception throughout the course of this study. * Must have a mean low-density lipoprotein cholesterol values bet...