Health-related quality of life (HRQoL) measures.Shift and proportion of subjects who attain all three of the following:.WHO/ New York Heart Association (NYHA) functional class.
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Medical condition in easily understood languageĭiseases - Cardiovascular Diseases Į.1.2 Medical condition or disease under investigation Medicinal product containing genetically modified organismsĮ.1 Medical condition or disease under investigation Immunological medicinal product (such as vaccine, allergen, immune serum) one involving a medical device)Ĭommittee on Advanced therapies (CAT) has issued a classification for this productĬombination product that includes a device, but does not involve an Advanced Therapy The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)Īctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e.
IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old.
Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). Extra features include video rescue features to lighten video & rescue video that appears clipped on the TV, support for both NTSC and PAL output, generic MPEG encoder, erases CDRWs.Allows you to search for protocol and results information on:
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