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Клинические исследования в Украине

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Исследования / № 00332917

Описание
Краткое названиеAn Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Полное названиеAn Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
СпонсорSolvay Pharmaceuticals
Industry
ИсточникSolvay Pharmaceuticals
Под контролемBelgium: Directorate general for the protection of Public health: Medicines
Finland: Finnish Medicines Agency
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency
Croatia: Ministry of Health and Social Care
Russia: Ministry of Health and Social Development of the Russian Federation
Ukraine: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Gobierne de Chile
South Africa: Medicines Control Council
Canada: Health Canada
New Zealand: Medsafe
United States: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Colombia: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Peru: Ministry of Health
Yes
Краткое описаниеThis is a multicenter, 6 months open label safety extension study for all patients who are
willing and eligible to continue from the pivotal, double-blind S308.3.001 trial
СостояниеЗавершено
Дата началаFebruary 2007
ФазаPhase 3
Вид исследованияAllocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Patients who have completed S308.3.001 trial

Exclusion Criteria:

- Patients with medically relevant abnormal findings (ECG, physical examination, AEs)
at end of the maintenance phase (visit M6, week 24) of study S308.3.001
ПолBoth
Минимальный возраст30 Years
Максимальный возрастN/A
УсловиеEarly Stage Parkinson's Disease
Применяемое лечение
DrugPardoprunox
Контакты и расположение
Kharkiv Site 183
Kharkiv Site 180
Kyiv Site 181
Kyiv Site 182
Lviv Site 185
Vinnitsa Site 184
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