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Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

2015-04-27 14:47:38 | BioPortfolio

Published on BioPortfolio: 2015-04-27T14:47:38-0400

Clinical Trials [627 Associated Clinical Trials listed on BioPortfolio]

Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from ...

Dabigatran Etexilate in Extended VTE Prevention After Hip Replacement Surgery

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in ...

Dabigatran Etexilate Compared With Enoxaparin in Prevention of VTE Following Total Hip Arthroplasty

The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and effic...

Safety and Tolerability of Dabigatran Etexilate in Adolescents

To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin PRN to maintain an INR of 2.0-3.0 for 6 mo...

PubMed Articles [1115 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate Oral Liquid Formulation in Infants with Venous Thromboembolism.

Venous thromboembolism (VTE) is more frequent in infants than in older children. Treatment guidelines in children are adapted from adult VTE data, but do not currently include direct oral anticoagulan...

Phase II study of dabigatran in children with venous thrombosis: pharmacokinetics, safety and tolerabilty.

The current standard-of-care treatments for pediatric venous thromboembolism (VTE) have limitations. Dabigatran etexilate (DE), a direct thrombin inhibitor, may offer an alternative therapeutic option...

Dabigatran versus Warfarin for Acute Venous Thromboembolism in Elderly or Impaired Renal Function Patients: Pooled Analysis of RE-COVER and RE-COVER II.

Management of acute venous thromboembolism (VTE) with anticoagulants in elderly patients and those with chronic kidney disease poses special challenges. The RE-COVER and RE-COVER II trials showed that...

5-FU-induced gastrointestinal damage impairs the absorption and anticoagulant effects of dabigatran etexilate.

Fluoropyrimidines, including 5-fluororacil (5-FU), cause gastrointestinal damage in the clinical setting and might affect the gastrointestinal absorption of concomitantly administered drugs. We aimed ...

The effect of dabigatran on thrombin generation and coagulation assays in rabbit and human plasma.

Dabigatran etexilate is widely used for stroke prevention in the patients with atrial fibrillation. The anticoagulation activity of dabigatran is not necessary monitored in routine clinical practice. ...

Medical and Biotech [MESH] Definitions

Impaired venous blood flow or venous return (venous stasis), usually caused by inadequate venous valves. Venous insufficiency often occurs in the legs, and is associated with EDEMA and sometimes with VENOUS STASIS ULCERS at the ankle.

Obstruction of a vein or VEINS (embolism) by a blood clot (THROMBUS) in the blood stream.

Instruments that generate intermittent forces, uniformed or graduated, to facilitate the emptying of VEINS. These devices are used to reduce limb EDEMA and prevent venous THROMBOEMBOLISM, such as deep vein thrombosis in the legs.

Rare vascular anomaly involving a communication between the intracranial and extracranial venous circulation via diploe, the central spongy layer of cranial bone. It is often characterized by dilated venous structures on the scalp due to abnormal drainage from the intracranial venous sinuses. Sinus pericranii can be congenital or traumatic in origin.

A vascular anomaly characterized by a radial or wedge-shaped arrangement of dilated VEINS draining into a larger vein in the brain, spinal cord, or the meninges. Veins in a venous angioma are surrounded by normal nervous tissue, unlike a CENTRAL NERVOUS SYSTEM CAVERNOUS HEMANGIOMA that lacks intervening nervous tissue. Drainage of venous angioma is fully integrated with the body's venous system, therefore, in most cases there is no clinical signs and rare bleeding.

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