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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00769132 | A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED) | PHASE1 | COMPLETED | 26 | — | — | Aug 3, 2007 | Nov 6, 2007 | Nov 21, 2019 | - | — |
The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | ER niacin/laropiprant + Placebo to laropiprant |
| B | ACTIVE_COMPARATOR | ER niacin + Placebo to laropiprant |
| C | EXPERIMENTAL | laropiprant + Placebo to ER niacin/laropiprant |
| D | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Comparator: niacin + laropiprant | DRUG | ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days |
| Comparator: niacin | DRUG | ER niacin 2 g tablet once daily for 7 days |
| Comparator: laropiprant | DRUG | laropiprant 40 mg once daily for 7 days |
| Comparator: placebo | DRUG | matching placebo tablets for each of the interventions once daily for 7 days |
Inclusion Criteria: * Female subjects may not be pregnant and/or will agree to use appropriate method of contraception beginning at least 2 weeks prior to administration of the first dose of study drug in the first treatment period, throughout the study and until at least 2 weeks after administrati...