Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
niacin/laropiprant · 2 trials · 5 indications
After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo
Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | Arm 1: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study. |
| 2 | ACTIVE_COMPARATOR | Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study. |
| ER niacin/laropiprant | EXPERIMENTAL | 1 g ER niacin plus 20 mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily |
| Placebo | ACTIVE_COMPARATOR | Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily |
| Name | Type | Description |
|---|---|---|
| ER niacin/laropiprant | DRUG | One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks. |
| Comparator : placebo (unspecified) | DRUG | ER niacin/laropiprant Placebo |
| simvastatin | DRUG | 40 mg simvastatin tablet orally per day as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level |
| ezetimibe/simvastatin | DRUG | 10 mg ezetimibe plus 40 mg simvastatin in single tablet taken once daily as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level |
Inclusion Criteria: * Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable dose of antidiabetic medication for at least 3 months Exclusion Criteria: * Patients taking Cholestin, niacin (\>50 mg/day), fibrate therapy, hormonal contraceptives, intermittent Hormone Re...