- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00844415
Safety and Tolerability of Dabigatran Etexilate in Adolescents
Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Alberta
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Edmonton, Alberta, Канада
- 1160.88.00002 Boehringer Ingelheim Investigational Site
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Ontario
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Ottawa, Ontario, Канада
- 1160.88.00001 Boehringer Ingelheim Investigational Site
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria:
- males or females 12 to less than 18 years of age
- objective diagnosis of primary VTE
- completion of planned treatment course with LMWH or OAC for primary VTE
- written informed consent by parent (legal guardian) and patient assent
Exclusion criteria:
- weight less than 32 kg
- conditions associated with increased risk of bleeding
- severe renal dysfunction or requirement for dialysis
- active infective endocarditis
- hepatic disease
- pregnant females or females not using medically accepted contraceptive method
- anemia or thrombocytopenia
- use of prohibited or restricted drug within previous week
- received investigational drug within past 30 days
- unreliable patients or patients who have any condition that would not allow safe participation in study
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: dabigatran etexilate
open label; patient to receive dabigatran etexilate BID for three days
|
2.14 mg/kg BID to a max 150 mg BID
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Number of Patients With Bleeding Events (Major and Minor)
Временное ограничение: From Screening until 30 days after first drug administration (end of trial visit)
|
Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria: Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. |
From Screening until 30 days after first drug administration (end of trial visit)
|
Number of Patients With Adverse Events
Временное ограничение: From Screening until 30 days after first drug administration (end of trial visit)
|
Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period.
Events were considered "on-treatment" if occurring within 72 hours after last drug administration.
|
From Screening until 30 days after first drug administration (end of trial visit)
|
Plasma Concentration of Free Dabigatran
Временное ограничение: 3 days
|
Plasma concentration of free dabigatran measured at 72 hours after first dose
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3 days
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Plasma Concentration of Total Dabigatran
Временное ограничение: Day 3
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Plasma concentration of total dabigatran measured at 72 hours after first dose
|
Day 3
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Thrombin Time (TT) Centrally Measured
Временное ограничение: Day 3
|
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
|
Day 3
|
TT Locally Measured
Временное ограничение: Day 3
|
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
|
Day 3
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Временное ограничение: Day 3
|
Measurement of aPTT was performed locally and centrally using validated assays.
|
Day 3
|
aPTT Locally Measured
Временное ограничение: Day 3
|
Measurement of aPTT was performed locally and centrally using validated assays.
|
Day 3
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Ecarin Clotting Time (ECT)
Временное ограничение: Day 3
|
Measurement of ECT was performed locally and centrally using validated assays.
Descriptive statistics is only performed for the centrally measured ECT.
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Day 3
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Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
Временное ограничение: Baseline and 3 days
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Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
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Baseline and 3 days
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Occurences of Clinical Outcome
Временное ограничение: 3 days
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Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location).
Number of patients with particular clinical outcome are reported.
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3 days
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1160.88
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .