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A Prospective, Randomised, Double-blind, Double-dummy Trial to Compare the Efficacy of Micardis® (Telmisartan) (80 mg p.o. Once Daily) and Valsartan (160 mg p.o. Once Daily) in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring
The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering diastolic blood pressure in patients who missed a dose of their medication, as measured by ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)
Details
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 440 |
| Start date | 2001-09 |
Conditions
- Hypertension
Interventions
- Telmisartan
- Valsartan
- Placebo
Primary outcomes
- Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose — Baseline, Day 41, Day 55
measured by ambulatory blood pressure monitoring (ABPM) - Change in mean DBP during the last 6 hours of the 24 hour dosing interval — up to 8 weeks