Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as dalcetrapib (RO4607381)
dalcetrapib · 8 trials · 3 indications
Number of cardiovascular events per patient per year
| Arm | Type | Description |
|---|---|---|
| Dalcetrapib | EXPERIMENTAL | Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care. |
| Placebo | PLACEBO_COMPARATOR | Placebo orally daily, on a background of contemporary, guidelines-based medical care. |
| Dalcetrapib (RO4607381) | EXPERIMENTAL | - |
| Dalcetrapib 300mg | EXPERIMENTAL | - |
| Dalcetrapib 600mg | EXPERIMENTAL | - |
| Dalcetrapib 900mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Background care | OTHER | Guidelines-based medical care |
| Placebo | DRUG | Matching dalcetrapib placebo orally daily |
| dalcetrapib | DRUG | 600 mg orally daily |
| Dalcetrapib (RO4607381) | DRUG | 600mg po daily |
| Evidence-based medical care for Acute Coronary Syndrome | DRUG | As prescribed |
| Pravastatin | DRUG | 40mg po daily for 12 weeks |
Inclusion Criteria: * Adult patients, \>/= 45 years of age * Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease * Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) ...
Dalcetrapib was developed for cardiovascular disease, including coronary heart disease, dyslipidemia, and peripheral arterial disease. It was studied in patients with stable coronary heart disease, recent acute coronary syndrome, and low HDL cholesterol. All trials are completed, and the drug remains investigational.
Dalcetrapib targets CETP, cholesteryl ester transfer protein. It is a CETP inhibitor small molecule. By inhibiting CETP, dalcetrapib was intended to raise HDL cholesterol levels, though its clinical development has not led to an approved product.
Dalcetrapib was developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical trial program for dalcetrapib, including the Phase 3 studies in cardiovascular disease.
Dalcetrapib reached Phase 3 clinical development. Six trials have been completed, including Phase 3 studies, and no trials are currently active. Dalcetrapib is not approved and remains an investigational drug.
Dalcetrapib has been studied in six completed trials, including NCT01516541, NCT01323153, NCT00697203, and NCT00658515. The largest, NCT00658515, enrolled 15,871 patients with stable coronary heart disease and recent acute coronary syndrome. All trials are completed.
Yes, dalcetrapib is also known as RO4607381. Both names refer to the same CETP inhibitor small molecule developed by Roche Holding AG for cardiovascular conditions. The alternative designation RO4607381 appears in several trial titles.