A prospective, open, randomized and comparative trial of the efficacy of a fixed-dose losartan/hydrochlorothiazide (Preminent) versus high-dose amlodipine using home blood pressure monitoring in the treatment of hypertension: ALPHABET Study

Phase 4

• Conditions: Hypertension

• Registration Number: JPRN-UMIN000002438
• Lead Sponsor: Jichi Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-03
• Study Completion: 2010-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with uncontrolled hypertension (DBP>120mmHg) 2) Patients with uncontrolled diabetes (HbAlc>8.0%) 3) History of myocardial infarction, cerebrocascular accidents or other bascular accidents within 3months prior to the screening 4) patients with cardiac insufficiency (over NYHA grade III) 5) Oatients with a precious history of gout attack or uncontrolled hyperuricemia (UA>8.0mg/dl) 6) Patients with renal failure (serum creatinine>2.0mg/dl) 7) Hepatic dysfunction (AST and/or ALT>100IU/l) 8) Patients with secondary hypertension (bilateral renal artery stenosis, primary aldosteronism, etc 9) Patients with malignant hypertension 10) Pregnant women and women of childbearing potential 11) History of serious adverse drug reaction to study drugs 12) The patient for whom it is difficult to receive informed consent (dementia, etc) 13) Other patients who are judged to be inappropriate for the study by the inverstigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Change from baseline in average of morning and evening blood pressure (MEave), morning-evening difference (MEdif) in self-measured BP at home after 8 weeks.

Secondary Outcome Measures

Name	Time	Method
-Change from baseline in clinic blood pressure after 8 weeks. -Achieving BP target at 8 weeks. -Change from baseline in mean 24-hour ABPM, morning BP, daytime BP and night time BP after 8 weeks. -Change from baseline in urinary albumin/ creatinine ratio, PWV, BNP and hs-CRP after 8 weeks.