Transcription of Clinical study protocol template - ClinicalTrials.gov
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Clinical study protocol template - ClinicalTrials.gov
Global Clinical Development - General Medicine QAW039/fevipiprantClinical Trial protocol CQAW039A2316 / NCT03215758A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthmaDocument type: Clinical Trial ProtocolEUDRACT number:2017-001273-16 Version number:00 (OriginalProtocol) Clinical trial phase:IIIR elease date:10- May-2017 Property of NovartisConfidentialMay not be used, divulged, published, or otherwise disclosedwithout the consent of NovartisClinical Trial protocol template Version (July 2016)NovartisConfidentialPage 2 Clinical Trial protocol (Version 00) protocol No. CQAW039A2316 Table of contentsTable of of of of of objectives and and related for study for dose/regimen, route of administration and duration of for choice ofcomparator .. and timing of interim analyses/design and and control assignment and randomization.
ATC anatomical therapeutic chemical ATS/ERS American Thoracic Society/European Respiratory Society AV atrioventricular BMI body mass index BTPS body temperature and pressure saturated BUN blood urea nitrogen CFR Code of Federal Regulations CK creatine kinase CK-MB creatine kinase isoenzyme MB
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