Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lapaquistat and atorvastatin · 7 trials · 1 indication
| 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...
Lapaquistat is an investigational small molecule being developed for Type 2 Diabetes, Dyslipidemia, Hypercholesterolemia, and Hyperlipidemias. It is in Phase 3 clinical development for these cardiovascular conditions. The drug is not approved and remains under investigation.
Lapaquistat is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule in Phase 3 clinical development for cardiovascular indications including dyslipidemia and hypercholesterolemia.
Lapaquistat is in Phase 3 clinical development. It is an investigational drug and has not been approved. Seven clinical trials have been completed, with no active trials currently ongoing. The trials enrolled a total of 4,649 participants.
Lapaquistat has completed seven clinical trials, including NCT00143663, NCT00256178, NCT00487994, and NCT00864643. These Phase 3 and Phase 2 trials studied the drug's effects on cholesterol levels in patients with dyslipidemia and hypercholesterolemia, both alone and with statins like simvastatin and atorvastatin.
Lapaquistat is the same as Lapaquistat Acetate. Clinical trials refer to the drug as Lapaquistat Acetate, which is the active pharmaceutical ingredient being studied in patients with dyslipidemia and hypercholesterolemia.