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

UMIN ID: UMIN000002071

Registered date:12/06/2009

Basic Information

• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2008/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Change 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 minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Exclusion 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

• Primary Sponsor: Hokuso hypertension study group
• Source(s) of Monetary Support: Osaka geriatric-diseases prevention association