MedPath

A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs. a high-dose angiotensin II receptor antagonist in hypertensive patients

Phase 4
Conditions
Hypertension
Registration Number
JPRN-UMIN000001279
Lead Sponsor
Vascular Care Network (VCN) Kamanza study group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients under treatment with diuretics 2) Patients with office systolic blood pressure ≥ 180mmHg or office diastolic blood pressure ≥ 110mmHg 3) Patients with malignant hypertension 4) Patients who have stroke, myocardial infarction or other critical vascular complications that required hospitalization within 6 months prior to informed consent 5) Patients with liver dysfunction (ALT [GOT] and/or AST [GPT] over three times the normal value) 6) Patients with renal failure (serum creatinine ≥2.0 mg/dL) 7) Patients with a gout attack or hyperuricemia (≥8.0mg/dL) 8) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 9) Patients with uncontrolled arrhythmia 10) Patients with severe valvular disease including mitral stenosis and incompetence of aortic valve 11) Patients with cardiac insufficiency (NYHA grade III or IV) 12) Patients with a history of hypersensitivity to ingredients of losartan potassium 13) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 14) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change and % change in blood pressure after 3months of treatment
Secondary Outcome Measures
NameTimeMethod
- Change and % change in serum uric acid and serum blood glucose level after 3, 6 and 12 months of treatment. - Change and % change in blood pressure after 6 and 12 months of treatment. - Change and % change in HbA1c, microalbuminuria and BNP after 6 and 12 months of treatment. - Safety throughout the treatment period
© Copyright 2025. All Rights Reserved by MedPath