Status:
COMPLETED
Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan
Lead Sponsor:
Tohoku University
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
20-79 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive pati...
Eligibility Criteria
Inclusion
- Patients who meet all of the following criteria.
- Patients with NYHA class II through IV chronic heart failure.
- Patients who have a history of hypertension or those who have antihypertensive medications.
- Patients who are aged 20 years or older and less than 80 years at the entry.
- Stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker.
- Patients who do not have angiotensin II receptor blocker.
Exclusion
- Patients who have renal dysfunction (serum creatinine \>=3.0mg/dL) or those who are receiving chronic hemodialysis.
- History of drug hypersensitivity to olmesartan.
- Patients who have severe liver dysfunction.
- History of angioedema.
- History of malignant tumor or life-threatening illness of poor prognosis.
- Pregnant or possibly pregnant patients.
- Cardiovascular surgery within 6months prior to the date of the entry.
- Acute myocardial infarction within 6 months prior to the date of the entry.
- Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry.
- Other patients deemed unsuitable as subjects of the study by the treating physician.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1145 Patients enrolled
Trial Details
Trial ID
NCT00417222
Start Date
November 1 2006
End Date
December 1 2013
Last Update
May 19 2014
Active Locations (1)
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1
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Sendai, Japan, 980-8574