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Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension

NCT06395194 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15313

Last updated 2024-05-02

No results posted yet for this study

Summary

The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial tested the hypothesis that for the same blood-pressure control, valsartan would reduce cardiac morbidity and mortality more than amlodipine in hypertensive patients at high cardiovascular risk. The present study investigates effects of valsartan and amlodipine on pre-specified secondary kidney outcomes.

Conditions

  • Essential Hypertension

Interventions

DRUG

Cardiac outcomes on treatment with valsartan

Patients who already were on treatment, discontinued their previous antihypertensive medications when randomized to one of the trial's masked study arms (valsartan or amlodipine) without a run-in phase ("rolled over"). Valsartan treatment started at a dosage of 80 mg daily. If BP did not reach \<140/90 mmHg, the valsartan dose was doubled to 160 mg, and then hydrochlorothiazide (12.5 mg and 25 mg daily) and other antihypertensive drugs were added in sequential steps.

DRUG

Cardiac outcomes on treatment with amlodipine

Patients who already were on treatment, discontinued their previous antihypertensive medications when randomized to one of the trial's masked study arms (valsartan or amlodipine) without a run-in phase ("rolled over"). Amlodipine treatment started at 5 mg daily. If BP did not reach \<140/90 mmHg, the amlodipine dose was doubled to 10 mg, and then hydrochlorothiazide (12.5 mg and 25 mg daily) and other antihypertensive drugs were added in sequential steps.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Sverre E Kjeldsen, MD, PhD · University Of Oslo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-27
Primary Completion
2003-09-05
Completion
2003-12-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06395194 on ClinicalTrials.gov