Effects of Telmisartan compared with Candesartan on ischemic cardiovascular events in high-risk hypertensive patients: a multi-center, prospective, randomized, open-labeled, blinded endpoints trial

UMIN ID: UMIN000001762

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Essential hypertension
• Date of first enrollment: 2009/04/01
• Target sample size: 1500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Telmisartan treatment
Candesartan treatment

Outcome(s)

• Primary Outcome: New or recurrent acute myocardial infarction, angina pectoris, and asymptomatic myocardial ischemia
• Secondary Outcome: All causes of mortality, cardiovascular death (myocardial infarction, stroke, aortic dissection, aortic rupture, etc.) New or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria are set as follow: 1. History of worsening of heart failure within the preceding 6 months 2. Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months 3. History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months 4. History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months 5. History of cerebral infarction, cerebral hemorrhage within the past 6 months 6. Congenital heart disease 7. Uncontrolled hypertension on treatment (eg, BP>180/110 mmHg) 8. Pregnant women or women of childbearing potential 9. Hepatic dysfunction (AST or ALT >100IU/L) 10. Renal impairment (serum creatinine level >2.0 mg per 100 ml) 11. Known hypersensitivity or intolerance to ARB

Related Information

• Primary Sponsor: Department of Cardiovascular Medicine, Kyoto Prefectural University School of Medicine
• Source(s) of Monetary Support: The Waksman Foundation of Japan INC.