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Table summary of clinical trials for ximelagatran back     pdf    short list

Clinical trials of ximelagatran (ximelagatran, xi-melagatran, Exanta, H 376 95, H 376-95, ) are available for the clinical conditions:


DVT prophylaxis

These trials are included in meta-analysis concerning: direct antithrombins in orthopedic surgery, antithrombotics in orthopedic surgery, antithrombotics in elective major knee surgery, antithrombotics in elective hip replacement,

ximelagatran vs Dalteparin
METHRO I ,2002 Melagatran 1–4 mg s.c. immediately before surgery, melagatran at 20.00 hours, then ximelagatran 6–24 mg orally b.d. for 6–9 days
versus
Dalteparin 5000 IU o.d., started evening before surgery for 6–9 days 		adults undergoing hip or knee replacement  Follow-up: 6–9 days
open
Swedish 
METHRO II ,2002 Melagatran 1–3 mg s.c. immediately before surgery,melagatran same day, then ximelagatran 8–24 mg orally b.d. for 7–10 days
versus
Dalteparin 5000 IU o.d., started evening before surgery for 7–10 days 		undergoing hip or knee replacement  Follow-up: 7–10 days
double-blind
 
ximelagatran vs Enoxaparin
Phase II (Heit) ,2001 Ximelagatran 8, 12, 18 or 24 mgorally b.d., at least 12 h after surgery for 6–12 days
versus
Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 6–12 days 		adults (age>18 years and weight at least 40 kg) undergoing knee replacements  Follow-up: 6–12 days
double-blind
North American 
Platinum (Colwell) ,2003 Ximelagatran 24 mg orally b.d., starting at least 12 h after surgery for 7–12 days
versus
Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 7–12 days 		adults undergoing hip replacement  Follow-up: 7–12 days
double-blind
USA, Canada, Israel, Mexico,Argentina, South Africa 
METHRO III ,2002 Melagatran 3 mg s.c. 4–12h after surgery, then ximelagatran24 mg orally b.d. for 7–10 days
versus
Enoxaparin 40 mg s.c. o.d. 12 h before surgery for 7–10 days 		hip or knee replacement  Follow-up: 8–11 days
double-blind
Europe, South Africa 
EXPRESS ,2003 Melagatran 2 mg s.c. up to 30 min before surgery, then melagatran 3 mg at least 8 hafter surgery, then ximelagatran 24 mg orally b.d. for 8–11 days
versus
Enoxaparin 40 mg s.c. o.d.,starting 12 h before surgery for 8–11 days 		hip or knee replacement  Follow-up: 8–11 days
double-blind
Europe 

Acute coronary syndrome

These trials are included in meta-analysis concerning: antithrombotics in patients with a recent ACS, new oral anticoagulants in all type of patients, antithrombotics in all type of patient, anticoagulant in All ACS (including AMI), direct factor Xa inhibitors in all type of patients,

ximelagatran vs placebo
ESTEEM ,2003 oral ximelagatran at doses of 24 mg, 36 mg, 48 mg, or 60 mg twice daily
versus
placebo 		patients who had had recent ST-elevation or non-STelevation myocardial infarction  Follow-up: 6 months
double-blind
 

Venous thrombosis

These trials are included in meta-analysis concerning: antithrombotics in all type of patients, new oral anticoagulants in all types of patients, direct factor Xa inhibitors in all type of patients, antithrombotics in secondary prevention of VTE, antithrombotics in patients with cancer,

ximelagatran vs discontinuation
THRIVE III ,2003 ximelagatran 24 mg twice daily for 18 months
versus
placebo for 18 months 		patients with venous thromboembolism who had undergone six months of anticoagulant therapy  Follow-up: 18 months
double blind
18 countries 
ximelagatran vs placebo
Schulman (subgroup) ,2003 extended treatment with Ximelagatran 24mg twice daily after initial anticoagulant treatment for 6 months
versus
placebo (initial anticoagulant treatment for 6 months) 		study subgroup of patients with active cancer in the previous 5 years treated for DVT or pulmonary embolism for 6 months without recurrence  Follow-up: 18 months
single blind and outcome ass.
 
ximelagatran (without LMWH) vs LMWH/VKA
THRIVE I ,2003 oral ximelagatran (24, 36, 48 or 60 mg twice daily) for 2 weeks
versus
dalteparin and warfarin for 2 weeks 		Patients with acute DVT   Follow-up:

 
Fiessinger ,2005 ximelagatran 36 mg twice daily
versus
subcutaneous enoxaparin, 1 mg/kg twice daily, for 5 to 20 days followed by warfarin adjusted to maintain an international normalized ratio of 2.0 to 3.0. 		patients with acute deep vein thrombosis  Follow-up:
double blind
 

Atrial fibrillation

These trials are included in meta-analysis concerning: new oral anticoagulants in all type of patients, antithrombotics in primary prevention of thromboembolic events, direct antithrombins in all type of patients,

ximelagatran vs warfarin standard dose
SPORTIF II (ximelagatran vs warfarin standard dose) ,2002 ximelegatran 20,40,60 mg twice daily
versus
warfarin standard dose(target INR 2-3) 		Medium to high risk patients with chronic non valvular atrial fibrillation.   Follow-up: 16 weeks
Open
Europe ,USA 
SPORTIF III ,2003 ximelagatran 36 mg twice daily
versus
warfarin standard dose (target INR 2-3) 		One or more stroke risk factor in addition to AF.High risk patients with non valvular atrial fibrillation.  Follow-up: 17.4 months
Open
europe,asia,australasia 
SPORTIF V ,2005 ximelegatran 36 mg twice daily
versus
warfarin standard dose(target INR 2-3) 		One or more stroke risk factor in addition to atrial fibrillation.High risk patients with non valvular atrial fibrillation.   Follow-up: 20 months
Double blind
north america 



Entry terms: xi-melagatran, ximelagatran, xi-melagatran, glycine, N-((1)1-cyclohexyl-2-((2)-((((4-(amino(hydroxyimino)methyl)phenyl)methyl)amino)carbonyl)-1-azetidinyl)2-oxoethyl)-ethyl ester, glycine, N-((1R)1-cyclohexyl-2-((2S)-((((4-(amino(hydroxyimino)methyl)phenyl)methyl)amino)carbonyl)-1-azetidinyl)2-oxoethyl)-ethyl ester, Exanta, H 376 95, H 376-95, melagatran, N-((R)-(((2S)-2-((-p-amidobenzyl)carbamoyl)-1-azetidinyl)carbonyl)cyclohexylmethyl)glycine




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