Approval Probability
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Adjusted LOA
ML Risk
MK-0524A · 3 trials · 5 indications
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.
| Arm | Type | Description |
|---|---|---|
| Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg | EXPERIMENTAL | After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks. |
| Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg | EXPERIMENTAL | After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks. |
| Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg | EXPERIMENTAL | After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks. |
| Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg | EXPERIMENTAL | After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks. |
| Placebo → MK-0524A 2g | PLACEBO_COMPARATOR | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days). |
| Placebo → Extended Release (ER)-Niacin 2g | ACTIVE_COMPARATOR | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days) |
| MK-0524A 2g | EXPERIMENTAL | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks). |
| MK-0524B 2g/20 mg | EXPERIMENTAL | Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks |
| MK-0524B 2g/40mg | EXPERIMENTAL | Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks |
| Atorvastatin 10 mg | ACTIVE_COMPARATOR | Atorvastatin 10 mg, orally, once daily for 12 weeks |
| Atorvastatin 20 mg | ACTIVE_COMPARATOR | Atorvastatin 20 mg, orally, once daily for 12 weeks |
| Atorvastatin 40 mg | ACTIVE_COMPARATOR | Atorvastatin 40 mg, orally, once daily for 12 weeks |
| Atorvastatin 80 mg | ACTIVE_COMPARATOR | Atorvastatin 80 mg, orally, once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Comparator: simvastatin | DRUG | - |
| MK-0524A | DRUG | Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet |
| Placebo | DRUG | - |
| MK-0524B | DRUG | - |
| ER Niacin | DRUG | - |
| Atorvastatin | DRUG | - |
| Simvastatin | DRUG | - |
Inclusion Criteria: * has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit * meets one of the following triglyceride (TG) criteria: 1. is on n...
MK-0524A is an investigational small molecule being developed for cardiovascular conditions, including primary hypercholesterolemia, mixed hyperlipidemia, dyslipidemia, and flushing. It has been studied in Phase 3 clinical trials for mixed hyperlipidemia and for flushing caused by niacin.
MK-0524A is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The drug has completed Phase 3 clinical trials.
MK-0524A has completed Phase 3 clinical trials. It is an investigational drug and remains in clinical development, with no approval status indicated. Two Phase 3 trials have been completed, along with earlier phase studies.
MK-0524A has been studied in two completed Phase 3 trials: NCT00289900, which enrolled 2,340 participants with mixed hyperlipidemia, and NCT00533611, which enrolled 330 participants to evaluate its effect on flushing caused by niacin. Both trials were randomized, double-blind, and placebo-controlled.
MK-0524A is distinct from MK-0524B. While MK-0524A was studied in Phase 3 trials for mixed hyperlipidemia and flushing, MK-0524B appears in a Phase 1 bioequivalence study (NCT00943124) involving 220 healthy volunteers with dyslipidemia.