CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3,031 enrolled
Drug / intervention
Valsartan +1 moredrug
Likely dose
Valsartan 40–160 mg per day, with additional antihypertensive agents added if neededAI-extracted
Key inclusion· 2
  • ✓Confirmed hypertension diagnosis
  • ✓At least one cardiovascular risk factor: diabetes, smoking, lipid disorder, prior IHD or stroke, obesity (BMI>25), NYHA Class II-III heart failure, or ECG abnormality (LVH)
Key exclusion· 8
  • ✕Prior treatment with any ARB
  • ✕Recent cardiac events: unstable angina, myocardial infarction, PTCA, or CABG within 6 months
  • ✕IHD within 6 months after PCI, stable but planned for PCI or CABG
  • ✕Severe, malignant, or secondary hypertension

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00149227
NCT00149227Phase 4Completed
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Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension

Kyoto Prefectural University of Medicine·interventional·Posted Sep 8, 2005·Updated Dec 12, 2012

In Brief

A Phase 4 clinical trial evaluating Valsartan and Non-ARB for Hypertension and 3 related conditions. Completed, enrolled 3,031 participants across 1 site.

Detailed Summary

The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Ischemic Heart Disease, Congestive Heart Failure, Stroke
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago

Interventions

Valsartandrug

Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.

Non-ARBdrug

'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs