drugset / Trial / NCT00546754

BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)

NCT00546754 ↗

Phase 3 Completed 808 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.

Timeline

Start
2007-05-01
Primary completion
2009-04-01
Completion
2009-05-01

Outcome

Missed primary endpoint

registry analysis (unspecified test); Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg; p = 0.395; ANOVA NCT00546754 ↗

registry analysis (unspecified test); Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg; p = 0.935; ANOVA NCT00546754 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Losartan Other / unclassified 50 mg —
Subject Losartan Other / unclassified 100 mg —
Comparator Valsartan Unknown 80 mg —
Comparator Valsartan Unknown 160 mg —
Comparator Hydrochlorothiazide Unknown 12.5 mg —
Comparator Hydrochlorothiazide Unknown 25 mg —

Indications