ONgoing Evaluation of depressor effect And Safety of combination therapy with Telmisartan and low-dose hydrochlorothiazide in patients with hypertension uncontrolled on amlodipin treatment

UMIN ID: UMIN000000778

Registered date:26/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: essential hypertension
• Date of first enrollment: 2007/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

12 week combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day.
Amlodipine (5 mg/day) is continuously administered. If blood pressure is not reach to lower than 140/90 mmHg, amlodipine can b eincreased to 7.5 mg/day.

Outcome(s)

• Primary Outcome: Changes in office blood pressure
• Secondary Outcome: 1) Home blood pressure in early morning and before going to bed 2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients)

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis 2) Administration of antihypertensives other than amlodipine 3) cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study 4) Serum creatinine >= 2.0 mg/dl 5) Severe hypertension (systolic or diastolic blood pressure >= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing) 6) Chronic heart failure (NYHA class>=III to VI) 7) Contraindication of telmisartan or hydrochlorothiazide 8) hyper- (>= 5.5 mEq/L) or hypo- (<=3.5 mEq/l) potassemia 9) Untreated hyperuricemia or uncontrolled hydrochlorothiazide (serum uric acid >= 8.0 mg/dl) 10) Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c >=9.0%), or patients who possess the risk of hypoglycemic attack 11) Patients inadequate for the study

Related Information

• Primary Sponsor: Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
• Source(s) of Monetary Support: Advanced Clinical Research Organization (ACRO)