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| Sponsor: | Population Health Research Institute |
|---|---|
| Information provided by: | Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00468923 |
Purpose
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 the investigators 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 11,000 women 60 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 20 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 |
|---|---|---|
|
Cardiovascular Disease Stroke |
Drug: Candesartan cilexetil/hydrochlorothiazide Drug: Rosuvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Heart Outcomes Prevention Evaluation-3 |
| Estimated Enrollment: | 11000 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Rosuvastatin
Rosuvastatin 10 mg vs placebo
|
Drug: Rosuvastatin
Rosuvastatin 10 mg once daily
|
|
Placebo Comparator: Candesartan/HCT
Candesartan 16 mg/HCT 12.5 mg vs placebo
|
Drug: Candesartan cilexetil/hydrochlorothiazide
Candesartan cilexetil 16 mg/hydrochlorothiazide 12.5 once daily
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Principal Investigator: | Salim Yusuf, DPhil FRCPC | McMaster University |
| Principal Investigator: | Eva Lonn, MD MSc FRCPC | McMaster University |
More Information
| Responsible Party: | Dr. Salim Yusuf, Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00468923 History of Changes |
| Other Study ID Numbers: | PHRI |
| Study First Received: | May 2, 2007 |
| Last Updated: | December 3, 2010 |
| 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 Chile: Instituto de Salud Publica de Chile China: Ethics Committee China: State Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Colombia: Institutional Review Board Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy India: Indian Council of Medical Research India: Institutional Review Board India: Ministry of Health Malaysia: Office of Deputy Director-General of Health Malaysia: Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Philippines: Department of Health Bureau Food and Drugs Slovakia: SUKL South Africa: Medicines Control Council Sweden: Medical Products Agency Sweden: Regional Ethical Review Board |
|
Primary prevention Cholesterol lowering Blood pressure lowering Cardiovascular disease prevention |
|
Cardiovascular Diseases Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Hydrochlorothiazide Candesartan cilexetil Candesartan Rosuvastatin Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Enzyme Inhibitors Lipid Regulating Agents |