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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00549757 |
The purpose of this study is to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus Cardiovascular Disease |
Drug: Aliskiren Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality |
Estimated Enrollment: | 8600 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Aliskiren
Aliskiren 300 mg OD
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2: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Type 2 diabetes and at least one of the following:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis | 862-778-8300 |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSPP100E2337 |
Study First Received: | October 24, 2007 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00549757 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: Ministry of Health; Canada: Health Canada; China: State Food and Drug Administration; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Guatemala: Ministry of health; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Italy: National Institute of Health; Japan: Pharmaceuticals and Medical Devices Agency; Korea: Food and Drug Administration; Lithuania: State Medicine Control Agency - Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Portugal: National Pharmacy and Medicines Institute; Singapore: Center for Drug Administration; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; Taiwan: Department of Health; Thailand: Ministry of Public Health; Turkey: General Directorate of Pharmaceuticals and Pharmacy; United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Venezuela: Ministry of Health and Social Development |
Type 2 diabetes mellitus renal morbidity and mortality cardiovascular disease micro-albuminuria |
macro-albuminuria RAAS renin inhibitor Reduced estimated glomerular filtration rate |
Metabolic Diseases Albuminuria Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Cardiovascular Diseases Glucose Metabolism Disorders |