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Клинические исследования в Украине

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Описание
Краткое названиеTelmisartan and Amlodipine Fixed Dose Combination Trial for the Treatment of Severe Hypertension
Полное названиеAn 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).
СпонсорBoehringer Ingelheim Pharmaceuticals
Industry
ИсточникBoehringer Ingelheim Pharmaceuticals
Под контролемBulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
France: AFFSAPS
Hungary: National Institute of Pharmacy, H-1051 Budapest
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Spain: Agencia Espa?±ola del medicamento y Productos Sanitarios (AEMPS) Subdirecci??n General de Medicamentos de uso humano Parque empresarial las Mercedes, edificio 8 C/ Campezo, 1 28022 Madrid / SPAIN
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration
Краткое описаниеThe primary objective of this trial is to demonstrate that following eight weeks of
treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first
line therapy in reducing mean seated trough cuff SBP compared to the monotherapies of
telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A
key secondary objective is to identify the duration of treatment required to demonstrate the
superiority of the FDC over both of the monotherapies.
СостояниеЗавершено
Дата началаMarch 2009
ФазаPhase 3
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

1. Ability to provide written informed consent in accordance with Good Clinical Practice
and local legislation

2. Age 18 years or older

3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP
greater than 95 mmHg at randomisation

4. Ability to stop any current antihypertensive therapy without unacceptable risk to the
patient (Investigators discretion)

Exclusion Criteria:

Mean in-clinic seated cuff SBP >/= 200 mmHg and/or DBP >/= 95 mmHg
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеHypertension
Применяемое лечение
Drugamlodipine
Drugtelmisartan
Drugtelmisartan and amlodipine
Контакты и расположение
Kharkov 1235.20.451 Boehringer Ingelheim Investigational Site
Kharkov 1235.20.460 Boehringer Ingelheim Investigational Site
Kharkov 1235.20.458 Boehringer Ingelheim Investigational Site
Kiev 1235.20.454 Boehringer Ingelheim Investigational Site
Kiev 1235.20.453 Boehringer Ingelheim Investigational Site
Kiev 1235.20.461 Boehringer Ingelheim Investigational Site
Kiev 1235.20.457 Boehringer Ingelheim Investigational Site
Kiev 1235.20.455 Boehringer Ingelheim Investigational Site
Kiev 1235.20.456 Boehringer Ingelheim Investigational Site
Lvov 1235.20.452 Boehringer Ingelheim Investigational Site
Odessa 1235.20.459 Boehringer Ingelheim Investigational Site
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