Request PDF on ResearchGate | Antimicrobianos y embarazo | The physiologic changes that occur during pregnancy result in pharmacokinetic. Dígale a su médico si usted está embarazada o planea quedar embarazada. No se conoce si methyldopa causará daño al bebé nonato. Sin embargo, tener. de Dugarte G. Evaluación de antihipertensivos en embarazadas: mepindolol y alfametildopa. Estudio prospectivo y randomizado. Rev Obstet Ginecol Venez.
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Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the enn and not add them to your search terms in the text field.
Trials with results Trials alfamdtildopa results Clear advanced search filters. Review by the Competent Authority or Ethics Committee in the country concerned. EU Clinical Trials Register.
Both Female Only Male Only. IMP with orphan designation in the indication. Trials with results Le without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. Title of the trial for alfametoldopa people, in easily understood, i. Study to test the efficacy of two doses of Rotigotine on depressive mood apathy associated with Parkinson’s Disease. The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product.
Combination product that includes a device, but does not involve an Advanced Therapy.
PRE-ECLAMPSIA – PowerPoint PPT Presentation
Degenerative disease of the nervous system. To assess the effects of rotigotine over placebo on improvement of apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson? To evaluate the change in quality of life, anhedonia, depressive symptoms, fatigue, cognitive impairment, apathy rated by the caregiver, safety, and tolerability in subjects with apathy in early-stage and advanced-stage idiopathic Parkinson? Subject is considered reliable and capable of adhering to the protocol, visit schedule or medication application according to the judgment of the investigator.
Subject is male or female and? Subject has idiopathic Parkinson? Subject has unsatisfactory control of Parkinson? Embraazo suffers from apathy associated with Parkinson?
If subject is taking an antidepressant drug, such as selective serotonin reuptake inhibitors SSRIsserotonin? Abstinence only is not an acceptable method. Subjects must agree to use adequate alfametilropa during the study and for 4 weeks after their final dose of rotigotine or longer, if required by local regulations.
El paciente es un hombre o una mujer y? Subject has previously participated in this study or subject has previously been assigned to treatment embarzo a study of the medication under investigation in this study.
Subject has participated in another study of an investigational medicinal product IMP or a medical device within the last 28 days prior to the Screening Visit or is currently participating in another study of an IMP or a medical device.
Subject has had prior therapy with a dopamine agonist within 28 days prior to the Baseline Visit. Subject discontinued from previous eh with embarxzo dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator. Subject has a history of chronic alcohol or drug abuse within the last 6 months.
Subject has any medical or psychiatric condition ie, bipolar disorder, dementia, hallucinations, or psychosis that, in the opinion of the investigator, could jeopardize or would compromise the subject?
Subject has received neuroleptics except clozapine and quetiapinedopamine releasing substances eg, methylphenidate or amphetaminedopamine modulating substances eg, reserpinealpha-methyldopa, metoclopramide, MAO-A inhibitors, budipine, or tolcapone within 28 days of the Baseline Visit. Subject has received electroconvulsive therapy within 12 weeks prior to the Screening Visit.
Subject is receiving current psychotherapy or behavior therapy while participating in this study. Subject has a history of deep brain stimulation. Subject has a known hypersensitivity to any components of the IMP or comparative drugs as stated in the protocol.
Subject has a significant skin disease that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or transdermal medications.
Subject has a lifetime history of suicide attempt including an actual attempt, interrupted attempt, or aborted attemptor has suicidal ideation in the past 6 months as indicated by a positive response? Subject has an atypical Parkinson? Subject who is currently lactating or pregnant or planning to become pregnant during the duration of the study. Subject has symptomatic orthostatic hypotension at Screening. Following titration up to 7 weeks and maintainance 12 weeks periods, up to 19 weeks total.
Change from Baseline to the end of Maintenance Period in the score of the AS rated by the caregiver where available?
PPT – PRE-ECLAMPSIA PowerPoint presentation | free to download – id: c-ZGE0Z
Change from Baseline to the end of Maintenance Period in the sum score of the 8-item Parkinson? The trial involves single site in the Member State concerned. Definition alfamrtildopa the end of the trial and justification where it is not the last visit of the last subject undergoing the trial. Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition. Following final visit, subjects will return to standard of care treatment as defined by their regular physician.