drugset / Trial / NCT00795847

Morning Hypertension and Preminent Therapy Study

NCT00795847

Phase 4 Completed 216 enrolled Kurume University
RandomizedParallel-groupOpen-labelTreatment

Summary

It is difficult to control morning hypertension in practical clinical situation. Angiotensin receptor blocker (ARB) and thiazide are suggested to be effective to maintain the antihypertensive effects for 24 hours. However, monotherapy sometimes is not enough to control blood pressure level in the next morning and there are little evidence of the combination therapy for morning hypertension. The investigators hypothesized that a losartan 50 mg/hydrochlorothiazide 12.5 mg combination drug, Preminent, is effective and safe for controling morning hypertension, compared with high-dose of losartan 100 mg, in Japanese. Patients with morning hypertension were randomized to preminent treatment group or high-dose losartan treatment group. The efficacy and safety were compared after 3-month treatment.

Timeline

Start
2008-11
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrochlorothiazide Unknown 12.5 mg
Subject Losartan Other / unclassified 50 mg
Subject Losartan Other / unclassified 100 mg

Indications