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A Morbidity-Mortality and Remodeling Study With Valsartan

NCT ID: NCT00133328

Last Updated: 2005-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension Ischemic Heart Disease Congestive Heart Failure

Keywords

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stroke myocardial infarction angina renal damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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valsartan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jikei University School of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Seibu Mochizuki, MD., PhD

Role: STUDY_CHAIR

The Jikei University School of Medicine

Locations

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The Jikei University School of Medicine

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Mochizuki S, Shimizu M, Taniguchi I, Kanae K, Yoshida S, Tajima N, Dahlof 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 Drugs Ther. 2004 Jul;18(4):305-9. doi: 10.1023/B:CARD.0000041250.00079.84.

Reference Type RESULT
PMID: 15367828 (View on PubMed)

Mochizuki S, Dahlof B, Shimizu M, Ikewaki K, Yoshikawa M, Taniguchi I, Ohta M, Yamada T, Ogawa K, Kanae K, Kawai M, Seki S, Okazaki F, Taniguchi M, Yoshida S, Tajima N; Jikei Heart Study group. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007 Apr 28;369(9571):1431-1439. doi: 10.1016/S0140-6736(07)60669-2.

Reference Type DERIVED
PMID: 17467513 (View on PubMed)

Other Identifiers

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JHS2002

Identifier Type: -

Identifier Source: org_study_id