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Клинические исследования в Украине

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Исследования / № 00994292

Описание
Краткое названиеStudy Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
Полное названиеA Randomized, Double-Blind, Placebo Controlled Multi-Center and Parallel Group Study of the Safety, Tolerability and Efficacy of YM150 in Combination With Standard Treatment in Secondary Prevention of Ischemic Vascular Events in Subjects With Acute Coronary Syndromes
СпонсорAstellas Pharma Inc
Industry
ИсточникAstellas Pharma Inc
Под контролемArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Directorate general for the protection of Public health: Medicines
Brazil: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - French Health Products Safety Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Mexico: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health and Social Development of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Department of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Yes
Краткое описаниеThe purpose of this study is to evaluate the safety and efficacy of various doses of YM150
(the experimental drug) in the prevention of ischemic vascular events in subjects with
recent acute coronary syndromes.
СостояниеИдет набор
Дата началаSeptember 2009
ФазаPhase 2
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Набор0
КритерииInclusion Criteria:

- has a diagnosis of STE-ACS, NSTE-ACS as index event according to accepted guidelines
such as the ESC or AHA guidelines

- has elevated cardiac biomarkers

Exclusion Criteria:

- is planned for myocardial revascularization (e.g., Coronary Artery Bypass Graft
(CABG) or elective or staged PCI) or any other invasive procedure with increased risk
for bleeding (i.e. elective surgical procedures) within 60 days after randomization

- has had recent stroke or TIA ?‰¤ 12 months prior to index event

- has persistent BP of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher
at baseline with or without medication

- has participated in another clinical trial of an investigational drug (including
placebo) or device within 30 days (or the limit set by national law, whichever is
longer) of signing informed consent for the present study

- has participated in any YM150 clinical trials

- requires ongoing parenteral or oral anticoagulant therapy

- has active bleeding or is in the opinion of the investigator at high risk of bleeding
during the study
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеAcute Coronary Syndrome
Применяемое лечение
DrugYM150
DrugPlacebo
Контакты и расположение
Dnipropetrovsk , 49006
Kharkiv , 61178
Kharkiv , 61002
Kharkiv , 61039
Kyiv , 02660
Kyiv , 02038
Kyiv , 02091
Kyiv , 03152
Kyiv , 03680
Lutsk , 43024
Vinnitsa , 21029
Zaporizhzhya , 69000
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