Hypertension with metabolic syndrome
Conditions
Sponsors
Hypertension in Metabolic syndrome CHIBA (HMS-CHIBA) Study group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Patients who met diagnostic criteria for definite or probable metabolic syndrome 2) Patients with essential hypertension, who have been previously treated with monotherapy of an ARB or a calcium channel blocker for more than 3 months, however, whose blood pressure has not been adequately controlled (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90mmHg) 3) Men and women aged 20 to 80 years at the time of the first visit. 4) Outpatients 5) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Patients with uncontrolled hypertension (diastolic blood pressure ≥ 110mmHg) 2) Patients with malignant hypertension 3) Patients with uncontrolled diabetes (HbA1c ≥8.0%) 4) Patients with uncontrolled hypertriglyceridemia (TG ≥400mg/dL) 5) Patients who have stroke, AMI and/or critical vascular complications that required hospitalization within 6 months prior to the intervention 6) Patients with liver dysfunction [GPT(ALT) over three times the normal value] 7) Patients with renal failure (serum creatinine ≥2.0 mg/dL) 8) Patients with a previous history of gout attack or uncontrolled hyperuricemia (≥8.0mg/dL) 9) Patients under treatment with insulin 10) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 11) Patients with uncontrolled arhythmia 12) Patients with severe valvular disease including mitral stenosis and incompetence of aortic valve 13) Patients with cardiac insufficiency (NYHA grade III or IV) 14) Patients with a history of hypersensitivity to ingredients of losartan potassium 15) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 16) Patients with a history of hypersensitivity to ingredients of dihydropyridines 17) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change and % change in blood pressure after 12 and 24 weeks of treatment (excluding change in systolic blood pressure after 12 weeks of treatment) - Change and % change in Adiponectin, 8OHdG, HOMA-R, microalbuminuria, hs-CRP after 12 and 24 weeks of treatment - Safety throughout the treatment period - For other laboratory test values, exploratory analysis is to be conducted to analyze variations within a group and/or between two groups. | — |
Countries
Japan
Contacts
Public ContactIchiro Tatsuno / Hideki Hanaoka
Graduate School of Medicine, Chiba University Clinical Cell Biology and Medicine
Outcome results
None listed