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Status:

TERMINATED

Valsartan in Cardiovascular Disease With Renal Dysfunction (The V-CARD) Study

Lead Sponsor:

Kumamoto University

Conditions:

Hypertension

Eligibility:

All Genders

30-85 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in p...

Detailed Description

It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases. That is called "cardiorenal syndrome". It was reported that valsartan was effective in r...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (all required):
  • Systolic blood pressure (SBP) \>/= 140 and/or diastolic blood pressure (DBP) \>/= 90 (untreated hypertension cases); or SBP\>/=130 and/or DBP\>/=80 (treated hypertension cases)
  • Patients with coronary artery disease (more than 50% stenosis on coronary angiography \[CAG\], coronary computed tomography \[CT\] or coronary magnetic resonance angiography \[MRA\]; coronary spasm; or history of percutaneous coronary intervention \[PCI\]);Unstable angina patient
  • Creatinine clearance between 30.0 and 89.9 ml/min
  • Exclusion Criteria (at least one of following):
  • Reduced left ventricular (LV) function (ejection fraction \[EF\] equal to or less than 40%)
  • Hyperpotassemia (serum potassium equal to or more than 5.5 mEq/l)
  • Rapid progressive glomerular nephritis
  • Nephrotic syndrome
  • Renal artery stenosis
  • Uncontrolled diabetes (HbA1c equal to or more than 9.0%)
  • History of allergy to valsartan
  • Pregnant women

Exclusion

    Key Trial Info

    Start Date :

    August 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2015

    Estimated Enrollment :

    1000 Patients enrolled

    Trial Details

    Trial ID

    NCT00140790

    Start Date

    August 1 2006

    End Date

    March 1 2015

    Last Update

    February 26 2016

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Department of Cardiovascular Medicine, Kumamoto University Hospital

    Kumamoto, Kumamoto, Japan, 860-8556

    2

    Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

    Kumamoto, Japan, 860-8556