drugset / Trial / NCT02177396

MICARDIS® and Valsartan in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring

NCT02177396

Phase 3 Completed 426 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary aim of the trial was to compare the effect of telmisartan and valsartan in lowering ambulatory diastolic and/or systolic blood pressure in the last six hours of the dosing interval. Secondary variables included changes from baseline in diastolic and systolic blood pressures during other times during the 24-hour ABPM profile, changes from baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff, and responder rates. Assessment of safety was also considered. Adverse events and use of concomitant therapies were monitored at each study visit. Blood pressure and heart rate were collected at each visit. Physical examination, electrocardiograms (ECG) and laboratory tests were completed during the trial as well.

Timeline

Start
1998-04
Primary completion
1998-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Telmisartan Other / unclassified 80 mg
Comparator Valsartan Small molecule 80 mg

Indications