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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00485758 | Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069) | PHASE3 | COMPLETED | 796 | — | — | Jul 1, 2007 | Aug 1, 2008 | Oct 12, 2015 | - | — |
After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo
| 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. |
| 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 |
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...