NIPH Clinical Trials Search

UMIN ID: UMIN000002071

Registered date:12/06/2009

Study on usefulness evaluation of aggressive antihypertensive therapy using ambulatory blood pressure measurement (ABPM)

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment2008/05/01
Target sample size200
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeChange and % change in ambulatory blood pressure measurement (ABPM) after 12weeks of treatment
Secondary Outcome- Change and % change in ABPM after 24 and 48 weeks of treatment - Effect on regression of heart hypertrophy, left ventricular mass index, augmentation index, and laboratory markers (MMP2, MMP9, TIMP, BNP) after 48 weeks of treatment - Change in office blood pressure after 12, 24 and 48 weeks of treatment - Safety throughout the treatment period - Exploratory subgroup analysis

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteriaExclusion criteria: 1) Patients under treatment with diuretics 2) Patients with uncontrolled hypertension (diastolic blood pressure ≥110mmHg) 3) Patients with malignant hypertension 4) Patients with cardiac failure (NYHA grade III or IV) 5) Patients with a previous history of gout attack or uncontrolled hyperuricemia (≥8.0mg/dL) 6) Patients who have stroke, AMI and/or critical vascular complications that required hospitalization within 6 months prior to the intervention 7) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 8) Patients with severe liver dysfunction 9) Patients with renal failure (serum creatinine ≥2.0 mg/dL) 10) Patients with a history of hypersensitivity to ingredients of losartan / HCTZ 11) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 12) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Related Information


public contact
Name Chikao Ibuki
Address Japan
Affiliation Hokuso hypertension study group secretariat Hokuso hypertension study group secretariat
scientific contact
Name Yoshihiko Seno
Address 1715 Kamakari, Inba-mura, Inba-gun, Chiba Japan
Telephone 0476-99-1111
Affiliation Nippon Medical School Chiba Hokusoh Hospital Internal medicine