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Also known as CORDAPTIVE™
MK0524A · 6 trials · 5 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| MK0524A, /Duration of Treatment : 4 Weeks | DRUG | - |
| Comparator : niacin /Duration of Treatment : 1 Weeks | DRUG | - |
| MK-0524A | DRUG | - |
| ER Niacin | DRUG | - |
| Placebo | DRUG | - |
| Atorvastatin | DRUG | - |
| Simvastatin | DRUG | - |
| Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks | DRUG | - |
| MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks | DRUG | - |
| Comparator : niacin / Duraton of Treatment: 4 Weeks | DRUG | - |
| MK0524A, /Duration of Treatment : 8 Weeks | DRUG | - |
| Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks | DRUG | - |
| Comparator: niacin / Duration of Treatment: 17 Weeks | DRUG | - |
| MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks | DRUG | - |
| Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks | DRUG | - |
Inclusion Criteria: * Patient is male or female between 18 and 70 years of age * Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Exclusion Criteria: * Patient has a history of hypersensitivity to niacin or niacin-containing p...
MK0524A is an investigational small molecule combination developed by Merck & Company, Inc. (MRK). It combines extended-release niacin with laropiprant and was studied for flushing and lipid disorders, including hypercholesterolemia, hypercholesteremia, and mixed hyperlipidemia. It is not described as approved and remains in clinical development.
MK0524A was studied for flushing and for cholesterol-related conditions: hypercholesteremia, hypercholesterolemia, and mixed hyperlipidemia. Its trials enrolled adults with flushing or hypercholesterolemia. The program is investigational, so these are studied indications rather than approved uses.
MK0524A is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical program, including the flushing and hypercholesterolemia studies registered as NCT00536237, NCT00533676, NCT00533611, and NCT00533312.
MK0524A reached Phase 3, with one Phase 3 trial among its registered studies. All three of its trials are completed and none are active, so the program is not currently enrolling. It is an investigational combination and is not described as FDA approved.
MK0524A has been studied in completed trials including NCT00536237 and NCT00533676 in flushing, NCT00533611, a Phase 3 study of flushing caused by niacin, and NCT00533312 in hypercholesterolemia. Across these studies, total enrollment was 2,340 participants, all adults aged 18 and older.