Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
dalcetrapib · 10 trials · 4 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 | - |
| Single Arm | EXPERIMENTAL | - |
| A | EXPERIMENTAL | RO5317116/F01 bilayer tablet |
| B | EXPERIMENTAL | RO5317116/F03 bilayer tablet |
| C | EXPERIMENTAL | RO5317116/F04 active-coated tablet |
| D | EXPERIMENTAL | RO4607381/F49 tablet |
| 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 |
| atorvastatin | DRUG | single dose of atorvastatin on day 1 |
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 is an investigational small molecule being studied for cardiovascular conditions including dyslipidemia, coronary heart disease, cardiovascular disease, and peripheral arterial disease (PAD). It has been evaluated in patients with coronary heart disease or those at elevated risk for cardiovascular disease. Dalcetrapib is not approved and remains in clinical development.
Dalcetrapib is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche has sponsored clinical trials of the drug in patients with coronary heart disease and related cardiovascular conditions. The drug is an investigational small molecule in the cardiovascular therapeutic area.
Dalcetrapib has completed Phase 2 and Phase 3 clinical trials. The most advanced completed study was a Phase 3 trial (NCT01516541) in patients with stable coronary heart disease or elevated cardiovascular risk. All six trials listed for Dalcetrapib are completed, with none currently active.
Dalcetrapib has been studied in six completed clinical trials, including NCT00353522, NCT00400439, NCT00655538, and NCT01516541. These trials evaluated the drug in patients with coronary heart disease, cardiovascular disease, dyslipidemia, and peripheral arterial disease. The largest trial, NCT01516541, enrolled 2,220 participants across multiple countries.
Dalcetrapib is a small molecule that targets cholesteryl ester transfer protein (CETP), which plays a role in lipid metabolism. By inhibiting CETP, the drug is designed to affect cholesterol transport and potentially improve lipid profiles in patients with cardiovascular conditions. This mechanism was studied in patients with dyslipidemia and coronary heart disease.
Yes, Dalcetrapib is also known as RO4607381. Clinical trials such as NCT00353522 and NCT00400439 used the name RO4607381 to refer to the drug. These studies evaluated the compound in patients with coronary heart disease or CHD risk equivalents.