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Abstract

In this chapter, several clinical trial examples will be presented which will be used in the remainder of the book to discuss different clinical trial situations in which composite endpoints might be applied and to illustrate possible planning and analysis strategies for studies with composite endpoints.

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References

  • Adzick, N. S., Thom, E. A., Spong, C. Y., Brock, J. W., Burrows, P. K., Johnson, M. P., et al. (2011). A randomized trial of prenatal versus postnatal repair of myelomeningocele. New England Journal of Medicine, 364, 993–1004.

    Article  Google Scholar 

  • Brenner, M. B., Cooper, M. E., de Zeeuw, D., Grunfeld, J.-P., Keane, W. F., Kurokawa, K., et al. (2000). The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of endpoints in NIDDM with the angiotensin II antagonist losartan). Journal of Renin-Angiotensin-Aldosterone System, 1, 328–335.

    Article  Google Scholar 

  • Brenner, M. B., Cooper, M. E., de Zeeuw, D., Keane, W. F., Mitch, W. E., Parving, H. H, et al. (2001). Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. New England Journal of Medicine, 345, 861–869.

    Article  Google Scholar 

  • Dahlöf, B., Devereux, R. B., de Faire, U., Fyhrguist, F., Beevers, G., de Faire, U., et al. (1997). The Losartan intervention for endpoint reduction (LIFE) in hypertension study: Rationale, design, and methods. American Journal of Hypertension, 10, 705–713.

    Article  Google Scholar 

  • Dahlöf, B., Devereux, R. B., Kjeldsen, S. E., Julius, S., Beevers, G., de Faire, U., et al. (2002). Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A randomised trial against atenolol. The Lancet, 359, 995–1003.

    Article  Google Scholar 

  • Dargie, H. J. (2000). Design and methodology of the CAPRICORN trial - A randomised double blind placebo controlled study of the impact of carvedilol on morbidity and mortality in patients with left ventricular dysfunction after myocardial infarction. European Journal of Heart Failure, 2, 325–332.

    Article  Google Scholar 

  • The CAPRICORN Investigators (2001). Effect of Carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: The CAPRICORN randomised trial. The Lancet, 357, 1385–1390.

    Article  Google Scholar 

  • The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators (2006). Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: A randomised controlled trial. The Lancet, 368, 1096–1105.

    Google Scholar 

  • Rauch, B., Schiele, R., Schneider, S., Diller, F., Victor, N., Gohlke, H., et al. (2010). OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction. Circulation, 122, 2152–2159.

    Article  Google Scholar 

  • Yuksel, N., Majumdar, S. R., Biggs, C., & Tsuyuki, R. T. (2010). Community pharmacist-initiated screening program for osteoporosis: Randomized controlled trial. Osteoporosis International, 21, 391–398.

    Article  Google Scholar 

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Rauch, G., Schüler, S., Kieser, M. (2017). Clinical Trial Examples. In: Planning and Analyzing Clinical Trials with Composite Endpoints. Springer Series in Pharmaceutical Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-73770-6_4

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