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          Institute: MPI für Herz- und Lungenforschung (W. G. Kerckhoff Institut)     Collection: Publikationen des W. G. Kerckhoff-Instituts     Display Documents

ID: 474492.0, MPI für Herz- und Lungenforschung (W. G. Kerckhoff Institut) / Publikationen des W. G. Kerckhoff-Instituts
End points and clinical trial design in pulmonary arterial hypertension
Authors:McLaughlin, V. V.; Badesch, D. B.; Delcroix, M.; Fleming, T. R.; Gaine, S. P.; Galie, N.; Gibbs, J. S.; Kim, N. H.; Oudiz, R. J.; Peacock, A.; Provencher, S.; Sitbon, O.; Tapson, V. F.; Seeger, W.
Date of Publication (YYYY-MM-DD):2009
Title of Journal:J am Coll Cardiol
Issue / Number:1 Suppl
Start Page:S97
End Page:107
Audience:Not Specified
Abstract / Description:New and emerging therapies might provide benefit in patients with pulmonary arterial hypertension. Their efficacy and safety will be compared with existing combination therapies in randomized clinical trials. Appropriate end points for these trials need to be identified: these will include exercise testing, the composite end point of time to clinical worsening, and hemodynamic markers, including advanced imaging modalities and biomarkers. Quality-of-life questionnaires are useful and important secondary end points; pulmonary arterial hypertension-specific questionnaires are currently being developed. Advantages and disadvantages of various trial designs, including placebo-controlled monotherapy or add-on trials, noninferiority studies, and withdrawal trials are also discussed.
Free Keywords:*Clinical Trials as Topic; *Endpoint Determination; Exercise Test; Hemodynamics; Humans; *Hypertension, Pulmonary/diagnosis/physiopathology/therapy; Quality of Life; Randomized Controlled Trials as Topic; Research Design; Respiratory Function Tests; Treatment Outcome
External Publication Status:published
Document Type:Article
Version Comment:Automatic journal name synchronization
Communicated by:N. N.
Affiliations:MPI für physiologische und klinische Forschung
External Affiliations:Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan 48109-0273, USA. vmclaugh@med.umich.edu
Identifiers:ISSN:1558-3597 (Electronic) 0735-1097 (Linking)
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