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Клинические исследования в Украине

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Описание
Краткое названиеA Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
Полное названиеA Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation
СпонсорDaiichi Sankyo Inc.
Industry
ИсточникDaiichi Sankyo Inc.
Под контролемUnited States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Belarus: Ministry of Health
Bosnia: Central Ethics Committee, Ministarstvo Zdravstva (Ministry of Health)
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Latvia: State Agency of Medicines
Mexico: Federal Commission for Protection Against Health Risks
Moldova: Central Ethics Committee, Drug Agency of Ministry of Health
Russia: Ethics Committee
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health. Central Ethics Committee
Yes
Краткое описаниеThis study is to assess the safety of a potential new drug DU-176b for the prevention of
stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation
(AF). The duration is 3 months of treatment and a 30 day follow-up visit.
СостояниеЗавершено
Дата началаJune 2007
ФазаPhase 2
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Набор0
КритерииInclusion Criteria:

1. Male or female, 18 to 80 years old.

2. Able to provide written informed consent.

3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)

4. A congestive heart failure, hypertension, age ?‰? 75 years, diabetes, and prior stroke
(CHADS2) index score of at least 2

Exclusion Criteria:

1. Subjects with mitral valve disease or previous valvular heart surgery

2. Known contraindication to any anticoagulant including vitamin K antagonists such as
warfarin

3. Known or suspected hereditary or acquired bleeding or coagulation disorder
ПолBoth
Минимальный возраст18 Years
Максимальный возраст80 Years
УсловиеAtrial Fibrillation
Применяемое лечение
DrugEdoxaban (DU-176b)
DrugEdoxaban (DU-176b)
DrugEdoxaban (DU-176b)
DrugEdoxaban (DU-176b)
Drugwarfarin
Контакты и расположение
Cherkassy
Chernigov
Chernivtsy
Dnepropetrovsk
Donetsk
Ivano-Frankovsk
Kiev
Lutsk
Lviv
Odessa
Poltava
Ternopil
Vinnitsa
Zaporozhye
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