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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00961636 | A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102) | PHASE3 | COMPLETED | 1,152 | — | — | Oct 1, 2009 | Jan 1, 2011 | Feb 16, 2015 | - | — |
| NCT00111891 | An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032) | PHASE2 | COMPLETED | 575 | — | — | Jun 1, 2005 | Aug 1, 2005 | Feb 17, 2017 | - | — |
| NCT00944645 | MK0524A Bioequivalence Study (0524A-059) | PHASE1 | COMPLETED | 188 | — | — | Oct 1, 2006 | Jan 1, 2007 | Jun 19, 2015 | - | — |
Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7\*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, \>0 to 0.5, \>0.5 to 1, \>1 to 2, \>2 to 3, and \>3 days per week.
Measure of rate of absorption of ER niacin
Measure of extent of absorption of ER niacin
Measure of extent of absorption of laropiprant
Measure of rate of absorption of laropiprant
| Arm | Type | Description |
|---|---|---|
| ERN/LRPT | EXPERIMENTAL | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
| ERN/LRPT then ERN | EXPERIMENTAL | One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks. |
| A | ACTIVE_COMPARATOR | MK0524A Source 1 (Phase III manufacturing site) |
| B | ACTIVE_COMPARATOR | MK0524A Source 2 (commercial manufacturing site) |
| Name | Type | Description |
|---|---|---|
| ER niacin (+) laropiprant (ERN/LRPT) | DRUG | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
| Extended-release niacin (ERN) | DRUG | Two 1g tablets ERN (2g total) once daily for 12 weeks. |
| Placebo to ERN/LRPT | DRUG | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks |
| niacin (+) laropiprant | DRUG | - |
| Comparator: placebo (unspecified) | DRUG | - |
| niacin (+) laropiprant (Source 1) | DRUG | Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods. |
| Comparator: niacin (+) laropiprant (Source 2) | DRUG | Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods. |
Inclusion Criteria: * Patient is a male, or a female who is unlikely to conceive, as indicated by meeting at least one of the following conditions: (a) Patient is a male.(b) Patient is a female of reproductive potential and either agrees to remain abstinent (if this form of birth control is accepte...