ATACAND®（candesartan cilexetil）.pptVIP

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ATACAND®（candesartan cilexetil）.ppt

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Regulatory (CR) ATACAND?(candesartan cilexetil) Cardiovascular and Renal DrugsAdvisory Committee Bethesda, Maryland July 18, 2002 ATACAND? Introduction and Regulatory Overview Cindy Lancaster, MS, MBA, JD Director, Regulatory Affairs AstraZeneca Agenda for Presentation Regulatory Overview Cindy Lancaster, MS, MBA, JD Director, Regulatory Affairs AstraZeneca Comparison of Vasilios Papademetriou, MD, Antihypertensive Efficacy DSc, FACCof Candesartan Cilexetil Professor of Medicineand Losartan Georgetown University Epidemiologic and Clinical William B. Kannel, MD, FACCSignificance of Incremental Professor of Medicine andChanges in Blood Public HealthPressure Boston University School of Medicine Summary Cindy Lancaster, MS, MBA, JD Director, Regulatory Affairs AstraZeneca Consultant and Sponsor Representatives Consultant Donald Vidt, MD, FACC Principal Investigator for Study 230 Consultant, Department of Hypertension and Nephrology, The Cleveland Clinic Foundation Professor of Medicine, Ohio State University AstraZeneca Eric Michelson, MD, FACC Senior Director, Clinical Research Conrad Tou, PhD Associate Director, Biostatistics Jennifer Sugg, MS Senior Statistical Scientist Glenn Carlson, MD Senior Director, Medical Introduction Regulatory HistoryAgency Interactions (1) Original NDA Included 1 positive comparative study versus losartan, SH-AHM-0001 Randomized, double-blind, multicenter, placebo-controlled, parallel-group, 8-wk duration Patients (N = 337) with a mean diastolic blood pressure of 95 to 114 mm Hg Compared candesartan cilexetil 8 and 16 mg QD,losartan 50 mg QD, and placebo The proposed labeling did not include comparator text versus losartan Regulatory HistoryAgency Interactions (2) Study 175—positive results versus losartan available in 1998 Randomized, double-blind, multicenter, titration-to-effect, parallel-group, 8-wk duration Patients (N = 332) with a mean diastolic blood pressure of 95 to 114 mm Hg Initiated treatm