22 completed, 10 terminated, 1 withdrawn. 13 Phase 3, 8 Phase 4, 7 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 8, Terminated 4, Withdrawn 1 |
| Phase 4 | 8 | Completed 4, Terminated 4 |
| Phase 1 | 7 | Completed 6, Terminated 1 |
| Phase 2 | 4 | Completed 4 |
Follow MK-0524: new trials by email Literature Review of MK-0524 trials Research Report on MK-0524
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART niacin/laropiprant, Placebo - HIV, Atherosclerosis | Phase 4 | Terminated | Calmy Alexandra | 4 | 2012-08-01 | 2019-10-08 |
| A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158) MK-0524A - Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia | Phase 1 | Terminated | Merck Sharp & Dohme LLC | 10 | 2012-06-01 | 2015-11-03 |
| A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155) Laropiprant, Placebo for Laropiprant - Rosacea | Phase 1 | Completed | Merck Sharp & Dohme LLC | 60 | 2011-11-01 | 2015-03-25 |
| Effect of Niacin in the Lipoprotein (a) Concentration Niacin/Laropiprant - Hypercholesterolemia | Phase 4 | Completed | Instituto Aragones de Ciencias de la Salud | 90 | 2011-10-01 | 2013-01-10 |
| Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease Extended release niacin/laropiprant, placebo - Coronary Artery Disease, Dyslipidemias | Phase 4 | Terminated | Daniel A. Siniawski | 32 | 2011-10-01 | 2023-09-21 |
| Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia Niacin/ Laropiprant - Hyperlipoproteinemia, Metabolic Syndrome | Phase 4 | Terminated | Ludwig-Maximilians - University of Munich | 12 | 2011-06-01 | 2014-04-10 |
| Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) ER niacin/laropiprant (ERN/LRPT), ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM), Simvastatin (SIM) - Primary Hypercholesterolemia, Mixed Dyslipidemia | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 1139 | 2011-05-01 | 2019-02-06 |
| Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133) Extended-release niacin/laropiprant (ERN/LRPT), Placebo - Primary Hypercholesterolemia, Mixed Dyslipidemia | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 1173 | 2011-03-01 | 2024-05-22 |
| A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118) Simvastatin, Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM), Extended Release (ER) niacin/laropiprant (N/LRPT) - Primary Hypercholesterolemia, Dyslipidemia | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 977 | 2011-02-04 | 2018-08-16 |
| Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119) Niacin (+) laropiprant - Hypercholesterolemia, Mixed Dyslipidemia | Terminated | Merck Sharp & Dohme LLC | 1166 | 2010-12-01 | 2015-04-21 | |
| Niacin/Laropiprant and Endothelial Function Niacin/laropiprant, Placebo - Coronary Heart Disease | Phase 4 | Completed | University Medical Centre Ljubljana | 60 | 2010-09-01 | 2011-10-06 |
| The Impact of Tredaptive on Flow-Mediated Dilation in Cardiac Patients Tredaptive (1 g extended release niacin+ 20 mg laropiprant), Placebo, Tredaptive - Coronary Artery Disease, Dyslipidemia | Phase 4 | Terminated | Sheba Medical Center | 8 | 2010-07-01 | 2016-10-19 |
| Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome tredaptive (nicotinic acid/ laropiprant), placebo - Polycystic Ovary Syndrome | Phase 4 | Completed | Hull University Teaching Hospitals NHS Trust | 34 | 2010-06-01 | 2019-07-15 |
| A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED) niacin (+) laropiprant, Comparator: aspirin, Comparator: clopidogrel - Primary Hypercholesterolemia, Mixed Hyperlipidemia | Phase 1 | Completed | Merck Sharp & Dohme LLC | 36 | 2009-11-01 | 2015-11-02 |
| A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102) ER niacin (+) laropiprant (ERN/LRPT), Extended-release niacin (ERN), Placebo to ERN/LRPT - Dyslipidemia | Phase 3 | Completed | Merck Sharp & Dohme LLC | 1152 | 2009-10-01 | 2015-02-16 |
| Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment Fenofibrate, Niacin plus laropiprant - Type 2 Diabetes Mellitus, Dyslipidemia | Phase 4 | Completed | Institut Investigacio Sanitaria Pere Virgili | 30 | 2009-02-01 | 2014-06-03 |
| Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082) niacin (+) laropiprant, placebo (unspecified) - Dyslipidemia | Phase 3 | Withdrawn | Merck Sharp & Dohme LLC | 2008-09-01 | 2015-04-09 | |
| 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) Comparator: niacin + laropiprant, Comparator: niacin, Comparator: laropiprant - Hypercholesterolemia | Phase 1 | Completed | Merck Sharp & Dohme LLC | 26 | 2007-08-03 | 2019-11-21 |
| A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(COMPLETED) Comparator: ER niacin (+) laropiprant, Comparator: ER niacin, Comparator: laropiprant - Type 2 Diabetes Mellitus | Phase 1 | Completed | Merck Sharp & Dohme LLC | 26 | 2007-08-01 | 2015-09-07 |
| Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069) ER niacin/laropiprant, Comparator : placebo (unspecified) - Diabetes Mellitus Type 2 | Phase 3 | Completed | Merck Sharp & Dohme LLC | 796 | 2007-07-01 | 2015-10-12 |
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Dyslipidemias (10) · Hypercholesterolemia (9) · Hyperlipoproteinemia Type II (6) · Diabetes Mellitus, Type 2 (3) · Coronary Artery Disease (2) · Coronary Disease (2) · Diabetes Mellitus (2) · Hyperlipidemias (2) · Atherosclerosis (1) · Cardiovascular Diseases (1) · Flushing (1) · Hyperlipoproteinemias (1) · Metabolic Syndrome (1) · Peripheral Arterial Disease (1) · Polycystic Ovary Syndrome (1)
Merck Sharp & Dohme LLC (24) · Calmy Alexandra (1) · Daniel A. Siniawski (1) · Hull University Teaching Hospitals NHS Trust (1) · Institut Investigacio Sanitaria Pere Virgili (1) · Instituto Aragones de Ciencias de la Salud (1) · Ludwig-Maximilians - University of Munich (1) · Sheba Medical Center (1) · University Medical Centre Ljubljana (1) · University of Oxford (1)
Spain (2) · United Kingdom (2) · Argentina (1) · Germany (1) · Israel (1) · Slovenia (1) · Switzerland (1)
Alexandra Calmy, MD (1) · Colin Baigent (1) · Fernando Civeira, MD (1) · Jane Armitage (1) · Klaus Parhofer, MD, Prof. (1) · Luis Masana, Professor (1) · Martin Landray (1) · Michael Shechter, MD, MA (1) · Shlomi Matetzky, MD (1) · Stephen L Atkin, FRCP, PhD (1) · Zhengming Chen (1)
PMID 21401833, PMID 22500948, PMID 19833861, PMID 17392721, PMID 19576324, PMID 19748656, PMID 20518948, PMID 21291812, PMID 22400810, PMID 22658147, PMID 22683042, PMID 24206527, PMID 24401089, PMID 24854458, PMID 24855368, PMID 25014686, PMID 25142778, PMID 25750540, PMID 27407053, PMID 29449329, PMID 30821829, PMID 31447131, PMID 31805983