A Phase 4 interventional study of valsartan and Conventional antihypertensive drugs in Chronic Kidney Disease and Hypertension, sponsored by KVT-Study Group. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-03-31.
Sponsored by KVT-Study Group · Phase 4, Interventional, and Treatment
The purpose of this study is to prove the hypothesis that the progression of renal and cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker valsartan is added to conventional antihypertensive therapy.
It is widely recognized that suppression of the renin-angiotensin system ameliorates progression of chronic kidney disease (CKD) and that CKD is an important risk factor for development of cardiovascular disease. However, it has not been fully clarified if amelioration of CKD leads to the lower incidence of cardiovascular disease. The purpose of this study is to determine whether the angiotensin II receptor antagonist valsartan, in combination with conventional antihypertensive therapy, will ameliorate progression of both CKD and cardiovascular disease. The primary outcome is courses of renal and cardiac function. The secondary outcome is a composite of a doubling of serum creatinine concentration, end-stage renal disease, myocardial infarction, coronary revascularization, stroke, hospitalization for unstable angina, hospitalization for heart failure or death from cardiovascular causes.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 312 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →This is the only study on the registry with KVT-Study Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: valsartan · Drug: Conventional antihypertensive drugs
Drug: Conventional antihypertensive drugs
valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
Also known as: Diovan 40mg or Diovan 80mg
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
Also known as: any antihypertensive drug except ARB
Course of renal and cardiac function
Time frame: every month for renal function and every year for cardiac function
Doubling of serum creatinine concentration
Time frame: every month
End-stage renal disease
Time frame: anytime when it occurs.
Myocardial infarction
Time frame: anytime when it occurs.
Coronary revascularization
Time frame: anytime when it occurs.
Stroke
Time frame: anytime when it occurs
Hospitalization for unstable angina
Time frame: anytime when it occurs.
Hospitalization for heart failure
Time frame: anytime when it occurs.
Death from cardiovascular causes
Time frame: anytime when it occurs.
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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