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

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 - ALPHABET Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002438

Enrollment

100

Registered

2009-09-03

Start date

2009-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Fixed-dose Losartan50mg / HCTZ 12.5mg tablet group Amlodipine10mg group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Hypertensive outpatients aged 20 to 79 years at the time of informed consent, regardless of sex 2) Untreated hypertensive patients. (SBP>140mmHg or DBP>90mmHg, SBP>130mmHg or DBP>80mmHg for diabetic patients)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
-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

Measure	Time frame
-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.	—

Countries

Japan

Contacts

Public ContactKazuomi Kario

Jichi Medical University School of Medicine Division of Cardiovascular Medicine, Department of Medicine

kkario@jichi.ac.jp0285-58-7344

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026