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Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT)

T

Tohoku University

Status and phase

Completed
Phase 3

Conditions

Chronic Heart Failure

Treatments

Drug: olmesartan medoxomil

Study type

Interventional

Funder types

Other

Identifiers

NCT00417222
2006-179

Details and patient eligibility

About

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 patients with stable chronic heart failure.

Enrollment

1,145 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,145 participants in 2 patient groups

Olmesartan medoxomil
Active Comparator group
Description:
olmesartan medoxomil
Treatment:
Drug: olmesartan medoxomil
Standard therapy
No Intervention group
Description:
Standard therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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