Antihypertensive effect of combination therapy of telmisartan and low dose hydrochrolthiazide in hypertemnsive patients

UMIN ID: UMIN000000798

Registered date:15/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Severe hypertensive patients with uncontrolled hypertension
• Date of first enrollment: 2007/08/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Continuous oral administration of amlodipine (5-7.5mg/day)
Switch to oral administration of telmisartan (40-80mg/day)+low-dose hydrochrolthiazide (12.5mg/day) combination therapy

Outcome(s)

• Primary Outcome: Changes of morning and evening home blood pressure
• Secondary Outcome: Changes in office blood pressure, uric acid, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, fast blood glucose and HbA1c

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Endocrine hypertension 2) Severe hypertension with office systolic blood pressure over 180mmHg and/or diastolic blood pressure over 90mmHg 3) Malignant hypertension 4) Continuous ventricular tachycardia or severe arrythmia (AV block II-III, Af etc) 5) Severe heart failure (NYHA III-IV) 6) Myocardial Infarction, Coronary bypass surgery, and Intervention therapy were performed within 6 months 7) Patients with exclusion criteria of amlodipine, telmisartan and hedrochrolthiazide 8) Serum creatinine >2.1mg/dl 9) Serum potassium >5.5mEq/l or <3.5mEq/l 10) Untreated hyperuricemia or treated hyperuricemia with UA>8.0mg/dl 11) ACEI, ARB and Diuretic treated patients 12) Uncontrolled diabetic patients (HbA1c>9.0%) and diabetic patients with insulin injection 13) Hypoglycemia 14) Hypersensitivity with telmisartan and hydrochrolthiazide 15) Patients who are inadequate to entry this study by physicians in charge

Related Information

• Primary Sponsor: Non profit Organization LINE
• Source(s) of Monetary Support: Non profit Organization LINE