Heart Outcomes Prevention Evaluation-3 (HOPE-3)
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ClinicalTrials.gov Identifier: NCT00468923 |
Recruitment Status :
Completed
First Posted : May 3, 2007
Last Update Posted : October 25, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Disease Stroke | Drug: Candesartan/HCT Drug: Rosuvastatin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12705 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Heart Outcomes Prevention Evaluation-3 |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Rosuvastatin
Rosuvastatin 10 mg vs placebo
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Drug: Rosuvastatin
Rosuvastatin 10 mg once daily |
Placebo Comparator: Candesartan/HCT
Candesartan 16 mg/HCT 12.5 mg vs placebo
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Drug: Candesartan/HCT
Candesartan 16 mg/HCT 12.5 once daily |
- The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. [ Time Frame: Biannually ]
- The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations [ Time Frame: Biannually ]
- Total mortality [ Time Frame: Biannually ]
- The components of the co-primary endpoints [ Time Frame: Biannually ]
- Renal Dysfunction [ Time Frame: Biannually ]
- Arterial revascularizations. [ Time Frame: Biannually ]
- New diagnosis of diabetes. [ Time Frame: Biannually ]
- All components of the co-primary and secondary outcomes [ Time Frame: Follow-up ]
- Cognitive function [ Time Frame: Follow-up ]
- Erectile dysfunction in men [ Time Frame: Biannually ]
- Myopathy (defined as muscle aches or pains accompanied by CK rise >10ULN). [ Time Frame: Biannually ]
- Rhabdomyolysis (defined as muscle pain and/or weakness associated with CK rise >10 ULN and evidence of acute renal dysfunction). [ Time Frame: Biannually ]
- Hospital admissions and the reason for admission. [ Time Frame: Biannually ]
- Cancer [ Time Frame: Biannually ]

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women aged > 60 years and men > 55 years
- At least one additional CV risk factor including:
- Waist/hip ratio ≥ 0.90 in men and ≥ 0.85 in women;
- History of current or recent smoking (regular tobacco use within 5 years)
- Low HDL cholesterol
- Dysglycemia
- Renal dysfunction
- Family history of premature CHD in first degree relatives
Exclusion Criteria:
- Documented clinically manifest atherothrombotic CVD
- Clear indication or contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy
- Symptomatic hypotension
- Chronic liver disease
- Inflammatory muscle disease
- Renal impairment
- Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
- Concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ACE inhibitor, or a thiazide diuretic
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial
- Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
- Concurrent use of an experimental pharmacological agent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468923
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Salim Yusuf's office, Principal Investigator, Population Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00468923 |
Other Study ID Numbers: |
HOPE-3 |
First Posted: | May 3, 2007 Key Record Dates |
Last Update Posted: | October 25, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data will be shared with participants in the study April/May 2016 |
Primary prevention Cholesterol lowering Blood pressure lowering Cardiovascular disease prevention |
Cardiovascular Diseases Candesartan Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |