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Sponsored by: |
Population Health Research Institute |
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Information provided by: | Population Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00468923 |
Heart disease and stroke are major causes of death and disability worldwide and are largely preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous studies have shown that certain drugs can effectively and safely lower cholesterol and blood pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in people who had already sustained a heart attack or a stroke, or in people with high cholesterol and blood pressure levels. However, most heart attacks and strokes occur in people with average ("normal") cholesterol and blood pressure. Therefore, in the HOPE-3 trial we will evaluate whether a cholesterol lowering drug, rosuvastatin, and a combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or together can reduce the risk of heart attacks, stroke and their sequelae in people without known heart disease and at average risk. The trial will enroll 10,000 women 65 years or older and men 55 years or older without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. Eligible and consenting individuals will be randomized to receive either the real study medications or placebo (dummy pills) and will be monitored for an average of 5 years. The rates of heart attacks, strokes, deaths and other cardiovascular complications will be compared between subjects receiving the real drugs and those on placebo. The study will include people from at least ten countries, will be monitored an international group of scientists and physicians and will be coordinated by the Population Health Research Institute at McMaster University. The study is expected to demonstrate that combined lipid lowering and blood pressure lowering will substantially lower the risk for cardiovascular diseases and may substantially change our approach to cardiovascular prevention.
Condition | Intervention | Phase |
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Cardiovascular Disease Stroke |
Drug: rosuvastatin calcium (10mg) Drug: candesartan cilexetil (16mg) / hydrochlorothiazide (12.5mg) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Heart Outcomes Prevention Evaluation–3 |
Estimated Enrollment: | 10000 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2013 |
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jane Shannon | hope3@cardio.on.ca | |
Contact: Andrea Rathe | hope3@cardio.on.ca |
Canada, Ontario | |
Hamilton General Hospital | Recruiting |
Hamilton, Ontario, Canada, L8L 2X2 |
Principal Investigator: | Salim Yusuf, DPhil FRCPC | McMaster University |
Principal Investigator: | Eva Lonn, MD MSc FRCPC | McMaster University |
Study ID Numbers: | PHRI |
Study First Received: | May 2, 2007 |
Last Updated: | June 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00468923 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Argentina: Human Research Bioethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency; Canada: Health Canada; Canada: Ethics Review Committee; China: Ethics Committee; China: State Food and Drug Administration; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Colombia: Institutional Review Board; India: Indian Council of Medical Research; India: Institutional Review Board; India: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Africa: Medicines Control Council; Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
Primary prevention Cholesterol lowering Blood pressure lowering Cardiovascular disease prevention |
Candesartan cilexetil Calcium, Dietary Rosuvastatin Cerebral Infarction |
Candesartan Stroke Angiotensin II Hydrochlorothiazide |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antilipemic Agents Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents |
Antihypertensive Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Membrane Transport Modulators Angiotensin II Type 1 Receptor Blockers Natriuretic Agents Therapeutic Uses Cardiovascular Diseases |