Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine

Launched by TOKYO UNIVERSITY · Jul 28, 2007

Keywords

ClinConnect Summary

In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with 5mg/day of amlodipine are divided the following two groups and BP response, laboratory data, and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 5 mg/day of amlodipine is administered for more than 3 months
• • Systolic or diastolic blood pressure \>= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
• • Outpatients
• Exclusion Criteria:
• • Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
• • Administration of antihypertensives other than amlodipine
• • Cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
• • Serum creatinine \>= 2.0 mg/dl
• • Severe hypertension (systolic or diastolic blood pressure \>= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
• • Chronic heart failure (NYHA class\>=III to VI)
• • Contraindication of telmisartan or hydrochlorothiazide
• • Hyper- (\>= 5.5 mEq/L) or hypo- (\<=3.5 mEq/l) potassemia
• • Untreated hyperuricemia or uncontrolled hyperuricemia (serum uric acid \>= 8.0 mg/dl)
• • Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c \>=9.0%), or patients who possess the risk of hypoglycemic attack
• • Patients inadequate for the study