Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: A randomised, placebo-controlled, double-blind phase 1 trial

The Lancet

Volumn 386, Issue 9994, 2015, Pages 680-690

  Glund, Stephan ^a   Stangier, Joachim ^a   Schmohl, Michael ^a   Gansser, Dietmar ^a   Norris, Stephen ^b   Van Ryn, Joanne ^a   Lang, Benjamin ^a   Ramael, Steven ^c   Moschetti, Viktoria ^a   Gruenenfelder, Fredrik ^a   Reilly, Paul ^b   Kreuzer, Jörg ^a  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^b BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^c SGS Life Science Services   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN ETEXILATE; IDARUCIZUMAB; BENZIMIDAZOLE DERIVATIVE; BLOOD CLOTTING FACTOR 10A INHIBITOR; MONOCLONAL ANTIBODY; PYRIDINE DERIVATIVE;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ANTICOAGULATION; APPLICATION SITE IRRITATION; ARTICLE; ASTHENIA; BACKACHE; BINDING AFFINITY; BLOOD CLOTTING; BLOOD CLOTTING TIME; BODY MASS; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; DYSPEPSIA; DYSPHAGIA; EPISTAXIS; ERYTHEMA; FAINTNESS; FATIGUE; FLU LIKE SYNDROME; GLUCOSURIA; HEART PALPITATION; HEMATOMA; HEMATURIA; HEMOSTASIS; HOT FLUSH; HUMAN; INFUSION RELATED REACTION; MALE; NORMAL HUMAN; OROPHARYNX PAIN; PARESTHESIA; PARTIAL THROMBOPLASTIN TIME; PHASE 1 CLINICAL TRIAL; POLYURIA; PRESYNCOPE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SKIN IRRITATION; SKIN MANIFESTATION; THORAX PAIN; THROMBIN TIME; TONSILLITIS; ADOLESCENT; CIRCULATION TIME; CLINICAL TRIAL; DRUG EFFECTS; DRUG INTERACTION; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; BENZIMIDAZOLES; BLOOD CIRCULATION TIME; BLOOD COAGULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG INTERACTIONS; FACTOR XA INHIBITORS; HEALTHY VOLUNTEERS; HUMANS; MALE; MIDDLE AGED; PYRIDINES; YOUNG ADULT;

EID: 84939469874     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)60732-2     Document Type: Article

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