MEDICINES CO /DE Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2017-12-21: Study NCT03399370; Company role Lead sponsor; Phase Phase 3; Status Completed.
- 2017-11-28: Study NCT03397121; Company role Lead sponsor; Phase Phase 3; Status Completed.
- 2017-11-01: Study NCT03400800; Company role Lead sponsor; Phase Phase 3; Status Completed.
- 2017-11-01: Study NCT03021083; Company role Collaborator; Phase Phase 4; Status Withdrawn.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2017-12-21 | NCT03399370 Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol | Lead sponsor | Phase 3 | Completed Results posted | ASCVD; Elevated Cholesterol | 1,561 | 2019-09-17 |
| 2017-11-28 | NCT03397121 Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) | Lead sponsor | Phase 3 | Completed Results posted | Heterozygous Familial Hypercholesterolemia; Elevated Cholesterol | 482 | 2019-09-17 |
| 2017-11-01 | NCT03400800 Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol | Lead sponsor | Phase 3 | Completed Results posted | ASCVD; Risk Factor, Cardiovascular; Elevated Cholesterol | 1,617 | 2019-08-27 |
| 2017-11-01 | NCT03021083 IONSYS Feasibility Study | Collaborator Lead: Hospital for Special Surgery, New York | Phase 4 | Withdrawn | Spinal Injury | 0 | 2017-11-01 |
| 2017-06-22 | NCT03159416 A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7) | Lead sponsor | Phase 1 | Completed | Renal Impairment | 31 | 2018-03-24 |
| 2017-01-24 | NCT02925416 Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection | Lead sponsor | Phase 4 | Completed Results posted | Skin Diseases, Bacterial | 22 | 2017-06-20 |
| 2016-12-13 | NCT02963311 A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH) | Lead sponsor | Phase 2 | Completed Results posted | Homozygous Familial Hypercholesterolemia | 9 | 2018-10-08 |
| 2016-05 | NCT02800590 Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy | Lead sponsor | Phase 2 | Completed | Colonoscopy | 150 | 2017-06 |
| 2016-01 | NCT02597127 Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) | Lead sponsor | Phase 2 | Completed Results posted | Atherosclerotic Cardiovascular Disease; Familial Hypercholesterolemia; Diabetes | 501 | 2017-06-07 |
| 2015-12-03 | NCT02678923 MDCO-216 Infusions Leading to Changes in Atherosclerosis: A Novel Therapy in Development to Improve Cardiovascular Outcomes - Proof of Concept Intravascular Ultrasound (IVUS), Lipids, and Other Surrogate Biomarkers Trial | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Acute Coronary Syndrome | 126 | 2016-10-26 |
| 2015-09-29 | NCT02452918 A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI) | Lead sponsor | Phase 4 | Completed Results posted | Acute Bacterial Skin and Skin Structure Infection | 17 | 2016-07-05 |
| 2015-07 | NCT02471690 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy | 56 | 2016-04 |
| 2015-06-29 | NCT02395653 Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants | Lead sponsor | Phase 3 | Completed Results posted | Pain, Postoperative | 71 | 2016-09-12 |
| 2015-06 | NCT02389907 Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care | Lead sponsor | Observational | Withdrawn | Postoperative Pain | 0 | 2015-08 |
| 2014-12-19 | NCT02565147 Bivalirudin Infusion for Ventricular Infarction Limitation | Lead sponsor | Phase 3 | Terminated Results posted | Acute Myocardial Infarction | 78 | 2016-06-14 |
| 2014-12 | NCT02314442 A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C) | Collaborator Lead: Alnylam Pharmaceuticals | Phase 1 | Completed | Hypercholesterolemia | 70 | 2015-11 |
| 2014-08 | NCT04592380 Clevidipine vs Placebo or Standard of Care for Dyspnea and Blood Pressure Control in AHF | Lead sponsor | Phase 3 | Withdrawn | Dyspnea; Hypertension; Acute Heart Failure | 0 | 2016-11 |
| 2014-06 | NCT02171065 PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial. | Collaborator Lead: Uppsala University | Not applicable | Completed Results posted | Acute Coronary Syndrome (ACS) | 902 | 2020-05 |
| 2014-04 | NCT02081443 In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients | Collaborator Lead: University of Florida | Not applicable | Completed Results posted | Coronary Artery Disease | 60 | 2015-10 |
| 2013-12-02 | NCT01979445 Cangrelor to Clopidogrel or Prasugrel Transition Study | Lead sponsor | Phase 2 | Completed Results posted | Coronary Artery Disease (CAD) | 15 | 2014-01-20 |
| 2013-09-24 | NCT01913483 ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial | Lead sponsor | Phase 3 | Terminated Results posted | Peripheral Endovascular Interventions; Bleeding | 732 | 2016-03-16 |
| 2013-07-01 | NCT01813435 GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation | Collaborator Lead: ECRI bv | Phase 3 | Completed Results posted | Coronary Artery Disease (CAD) | 15,991 | 2018-04-26 |
| 2013-06 | NCT01852019 Cangrelor Prasugrel Transition Study | Lead sponsor | Phase 2 | Completed Results posted | Coronary Artery Disease | 12 | 2013-07 |
| 2013-01 | NCT01766466 Cangrelor Ticagrelor Transition Study | Lead sponsor | Phase 2 | Completed Results posted | Coronary Artery Disease | 12 | 2013-02 |
| 2012-10 | NCT01651780 Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH | Lead sponsor | Phase 3 | Completed Results posted | Severe Aortic Stenosis; Transcatheter Aortic Valve Replacement; Aortic Valve Replacement | 803 | 2015-06 |
| 2012-09 | NCT01860105 Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation | Lead sponsor | Phase 1 | Completed | Pharmacokinetics and Pharmacodynamics in Healthy Volunteers | 37 | 2013-01 |
| 2012-03 | NCT01530399 Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery | Lead sponsor | Phase 2 | Terminated Results posted | Bleeding | 44 | 2012-11 |
| 2011-12 | NCT01480531 Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection | Collaborator Lead: Duke University | Not applicable | Withdrawn | Aorta Aneurysm; Dissection of Aorta | 0 | 2012-12 |
| 2011-11 | NCT01526876 The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured Patients | Collaborator Lead: Columbia University | Phase 4 | Withdrawn | Hypertension | 0 | 2012-12-19 |
| 2011-08 | NCT01406236 SAFE-PCI for Women | Collaborator Lead: Duke University | Not applicable | Terminated | Percutaneous Coronary Intervention; Ischemic Symptoms | 1,787 | 2013-09 |
| 2010-11 | NCT01535222 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery | Lead sponsor | Phase 2 | Completed Results posted | Coronary Artery Bypass Graft; Cardiopulmonary Bypass | 32 | 2011-06 |
| 2010-09 | NCT01156571 A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) | Lead sponsor | Phase 3 | Completed Results posted | Atherosclerosis; Percutaneous Coronary Intervention; Acute Coronary Syndrome | 11,145 | 2012-12 |
| 2010-05 | NCT01042574 The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy | Collaborator Lead: Methodist Healthcare - Memphis | Phase 4 | Withdrawn | Hypertension; Intracranial Hemorrhage; Subarachnoid Hemorrhage | 0 | 2010-12-31 |
| 2010-03 | NCT01087723 European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial | Lead sponsor | Phase 3 | Completed Results posted | Acute Coronary Syndrome | 2,198 | 2014-08 |
| 2009-11 | NCT01033370 A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT) | Collaborator Lead: Asma Zainab, M.D. | Phase 4 | Terminated | Aortic Aneurysm; Aortic Disease | 5 | 2012-08 |
| 2009-07 | NCT00952081 A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients | Collaborator Lead: NYU Langone Health | Phase 4 | Completed Results posted | Hypertension; Brain Tumor; Epilepsy | 22 | 2010-02 |
| 2009-06 | NCT00978822 Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage | Collaborator Lead: Henry Ford Health System | Phase 2 | Terminated Results posted | Subarachnoid Hemorrhage; Hypertension | 5 | 2012-12 |
| 2009-05 | NCT01011504 Utilisation of Angiox® in European Practice | Lead sponsor | Observational | Completed | Stable Angina (SA); NSTE-ACS (NSTEMI and UA); STEMI (STE-ACS) | 2,019 | 2010-12 |
| 2008-12 | NCT00842374 Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin | Collaborator Lead: Minneapolis Heart Institute Foundation | Observational | Completed | Non-STEMI Acute Coronary Syndrome | 32 | 2012-12 |
| 2008-12 | NCT00803634 Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO) | Lead sponsor | Phase 3 | Completed Results posted | Hypertension; Heart Failure | 117 | 2012-03 |
| 2008-11 | NCT00799604 Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT) | Lead sponsor | Phase 2 | Completed Results posted | Hypertension | 30 | 2009-10 |
| 2008-10 | NCT00767507 Maintenance of Platelet Inhibition With Cangrelor | Lead sponsor | Phase 2 | Completed Results posted | Acute Coronary Syndrome (ACS) | 221 | 2011-07 |
| 2008-09 | NCT00759083 Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients | Lead sponsor | Phase 4 | Withdrawn | Heparin-Induced Thrombocytopenia; Heparin-induced Thrombocytopenia and Thrombosis Syndrome | 0 | 2010-05-10 |
| 2008-06 | NCT00699504 Assess the Effect of Cangrelor at the Therapeutic Dose and a Supratherapeutic Dose Level on the QT/QTc Interval in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy | 67 | 2008-11 |
| 2008-06 | NCT00666328 Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE) | Lead sponsor | Phase 3 | Completed Results posted | Hypertension; Hemorrhage | 37 | 2010-04 |
| 2007-08 | NCT00503126 Bivalirudin as a Procedural Anticoagulant in Pediatrics | Lead sponsor | Phase 2 | Completed | Cardiology | 110 | 2008-07 |
| 2006-09 | NCT00476944 Comparing Bivalirudin Versus Heparin/ GP IIB/IIA in Patients Undergoing PCI | Collaborator Lead: Gold, Herman K., MD | Phase 4 | Unknown | Coronary Artery Disease | ||
| 2006-09 | NCT00385138 Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition. | Lead sponsor | Phase 3 | Terminated Results posted | Atherosclerosis; Acute Coronary Syndrome (ACS) | 5,364 | 2010-06 |
| 2006-09 | NCT00369837 Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY) | Lead sponsor | Phase 3 | Completed | Hypertension | 131 | 2007-02 |
| 2006-04 | NCT00305162 A Clinical Trial to Demonstrate the Efficacy of Cangrelor | Lead sponsor | Phase 3 | Terminated Results posted | Myocardial Infarction (MI); Acute Coronary Syndromes (ACS) | 8,882 | 2010-06 |
| 2005-03 | NCT00433966 Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction | Collaborator Lead: Cardiovascular Research Foundation, New York | Phase 3 | Completed Results posted | Myocardial Infarction | 3,602 | 2010-11 |
| 2005-03 | NCT00102674 Pharmacokinetics/Pharmacodynamics (PK/PD) of Cangrelor | Lead sponsor | Phase 1 | Completed | Healthy | 40 | 2005-05 |
| 2004-08 | NCT00419055 Outpatient Percutaneous Coronary Intervention | Collaborator Lead: University of Pennsylvania | Observational | Terminated | Coronary Artery Disease | 100 | 2006-08 |
| 2004-06 | NCT00093912 Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP) | Lead sponsor | Phase 3 | Completed | Hypertension | 739 | 2006-11 |
| 2004-05 | NCT00093925 Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC) | Lead sponsor | Phase 3 | Completed | Hypertension | 739 | 2006-09 |
| 2004-04 | NCT00093886 Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG) | Lead sponsor | Phase 3 | Completed | Hypertension | 629 | 2005-04 |
| 2004-04 | NCT00093184 Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI | Lead sponsor | Phase 3 | Completed | Myocardial Infarction | 300 | 2005-12 |
| 2004-04 | NCT00079586 Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB) | Lead sponsor | Phase 3 | Completed | Cardiovascular Disease; Coronary Artery Bypass Surgery | 150 | 2004-11 |
| 2004-04 | NCT00079508 Angiomax in Patients With HIT/HITTS Type II Undergoing CPB | Lead sponsor | Phase 3 | Completed | Cardiovascular Disease; Coronary Artery Bypass Surgery | 125 | |
| 2004-01 | NCT00093249 Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1) | Lead sponsor | Phase 3 | Completed | Hypertension | 105 | 2004-11 |
| 2003-12 | NCT00093262 Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2) | Lead sponsor | Phase 3 | Completed | Hypertension | 206 | 2004-10 |
| 2003-10 | NCT00073580 Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE) | Lead sponsor | Phase 3 | Completed | Thrombocytopenia; Thrombosis; Cardiac Disease; Coronary Artery Bypass Surgery | 88 | |
| 2003-08 | NCT00093158 Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS) | Lead sponsor | Phase 3 | Completed | Unstable Angina; Myocardial Infarction; Acute Disease | 13,800 | 2007-01 |
| 2003-08 | NCT00073593 Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB | Lead sponsor | Phase 3 | Completed | Cardiac Surgery; Coronary Artery Bypass Surgery | 150 | |
| 2002-08 | NCT00043277 Study Of Angiomax In Infants Under Six Months With Thrombosis | Lead sponsor | Phase 2 | Completed | Thrombosis | 25 | 2004-12 |
| 1999-04 | NCT00043940 Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning) | Lead sponsor | Phase 3 | Completed | Heparin-Induced Thrombocytopenia; Thrombosis | 50 |