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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tokyo University
• Treatments: Amlodipine; Hydrochlorothiazide; Telmisartan

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