Исследования / № 00332917
| Описание | |
|---|---|
| Краткое название | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients |
| Полное название | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients |
| Спонсор | Solvay Pharmaceuticals Industry |
| Источник | Solvay Pharmaceuticals |
| Под контролем | Belgium: 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 |
| Краткое описание | This 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 |
| Состояние | Завершено |
| Дата начала | February 2007 |
| Фаза | Phase 3 |
| Вид исследования | Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Набор | 0 |
| Критерии | Inclusion 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 |
| Пол | Both |
| Минимальный возраст | 30 Years |
| Максимальный возраст | N/A |
| Условие | Early Stage Parkinson's Disease |
| Применяемое лечение | |
|---|---|
| Drug | Pardoprunox |
| Контакты и расположение | |
|---|---|
| Kharkiv | Site 183 |
| Kharkiv | Site 180 |
| Kyiv | Site 181 |
| Kyiv | Site 182 |
| Lviv | Site 185 |
| Vinnitsa | Site 184 |
