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Клинические исследования в Украине

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Исследования / № 01106014

Описание
Краткое названиеACT-293987 in Pulmonary Arterial Hypertension
Полное названиеA Multicenter, Double-blind, Placebo-controlled Phase 3 Study to Demonstrate the Efficacy and Safety of ACT-293987 in Patients With Pulmonary Arterial Hypertension
СпонсорActelion
Industry
ИсточникActelion
Под контролемUnited States: Food and Drug Administration
United States: Institutional Review Board
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
France: Afssaps - French Health Products Safety Agency
France: Institutional Ethical Committee
Ireland: Irish Medicines Board
Ireland: Research Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Solvak Republic: Ethics Committee
Slovakia: State Institute for Drug Control
Spain: Comit?© ?‰tico de Investigaci??n Cl?­nica
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Taiwan: Department of Health
Taiwan: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Austria: Ethikkommission
Belarus: Ministry of Health
China: State Food and Drug Administration
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
India: Drugs Controller General of India
India: Institutional Review Board
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health and Social Development of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Serbia: Ethics Committee
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Switzerland: Swissmedic
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Turkey: Ethics Committee
Turkey: Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Poland: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Switzerland: Ethikkommission
Yes
Краткое описаниеThe AC-065A302 GRIPHON study is an event-driven Phase 3 study to demonstrate the effect of
ACT-293987 on time to first clinical worsening in patients with pulmonary arterial
hypertension.
СостояниеИдет набор
Дата началаDecember 2009
ФазаPhase 3
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Male and female patients 18-75 years old, with symptomatic PAH

- PAH belonging to the following subgroups of the updated Dana Point Clinical
Classification Group 1 Idiopathic, or Heritable, or Drug or toxin induced, or
Associated (APAH) with Connective tissue disease, Congenital heart disease with
simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV
infection

- Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at
any time prior to Screening

- Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks
prior to the Baseline Visit

- Ability and willingness to refrain from sunbathing, prolonged sun exposure, and
artificial sunlight exposure and to limit skin and eye exposure to sunlight using
appropriate precautions from the first dose until 14 days after study drug
discontinuation

- Signed informed consent

Exclusion Criteria:

- Patients with pulmonary hypertension (PH) in the Updated Dana Point Classification
Groups 2-5, and PAH Group 1 subgroups that are not covered by the inclusion criteria.

- Patients who have received prostacyclin or its analogs within 1 month before Baseline
Visit, or are scheduled to receive any of these compounds during the trial.

- Patients with moderate or severe obstructive lung disease

- Patients with moderate or severe restrictive lung disease

- Patients with moderate or severe hepatic impairment (Child-Pugh B and C).

- Patients with documented left ventricular dysfunction

- Patients with severe renal insufficiency.

- Patients with BMI <18.5 Kg/m2.

- Patients who are receiving or have been receiving any investigational drugs within 1
month before the Baseline Visit.

- Acute or chronic impairment (other than dyspnea), limiting the ability to comply with
study requirements, in particular with 6MWT

- Recently conducted or planned cardio-pulmonary rehabilitation program based on
exercise training.

- Psychotic, addictive or other disorder limiting the ability to provide informed
consent or to comply with study requirements.

- Life expectancy less than 12 months.

- Females who are lactating or pregnant or plan to become pregnant during the study.

- Known hypersensitivity to any of the excipients of the drug formulations.
ПолBoth
Минимальный возраст18 Years
Максимальный возраст75 Years
УсловиеPulmonary Arterial Hypertension
Применяемое лечение
DrugACT-293987
DrugPlacebo
Контакты и расположение
Dnipropetrovsk , 49060"Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""
Kharkiv , 61124Health Care Municipal Institution, City Clinical Hospital #13
Kyiv , 03680Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"
Lviv , 79010Lviv Regional Clinical Hospital
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