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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00133328
Other study ID # JHS2002
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received August 22, 2005
Last updated October 27, 2005
Start date January 2002
Est. completion date November 2005

Study information

Verified date January 2002
Source Jikei University School of Medicine
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.


Description:

Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. However, it is a problem that the number of Asian patients is very little in these trials. The researchers examine the treatment meaning by ARB about the prognosis of the patient who amalgamates either among high blood pressure, the ischemic heart disease, and congestive heart failures.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3000
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure

Exclusion Criteria:

- Pregnancy

- Severe renal damage

- Severe liver damage

- Acute myocardial infarction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
valsartan


Locations

Country Name City State
Japan The Jikei University School of Medicine Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Jikei University School of Medicine

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Mochizuki S, Shimizu M, Taniguchi I, Kanae K, Yoshida S, Tajima N, Dahlöf B; JIKEI HEART Study Group. JIKEI HEART Study--a morbi-mortality and remodeling study with valsartan in Japanese patients with hypertension and cardiovascular disease. Cardiovasc Dr — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary stroke
Primary new or recurrent transient ischemic attack
Primary new or recurrent acute myocardial infarction
Primary new occurrence or exacerbation of heart failure
Primary new occurrence or exacerbation angina pectoris
Primary dissecting aneurysm of the aorta
Primary lower limb arterial obstruction
Primary transition to dialysis
Primary doubling of plasma creatinine (Cr) levels
Secondary death from any cause
Secondary left ventricular hypertrophy
Secondary changes in ECG
Secondary proteinuria
Secondary B-type natriuretic peptide (BNP)
Secondary heart failure symptoms
Secondary heart failure syndrome (edema, rales on auscultation)
Secondary blood pressure and heart rate
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