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

Tokyo University

Status and phase

Completed

Phase 4

Conditions

Essential Hypertension

Treatments

Device: Amlodipine

Drug: telmisartan plus hydrochlorothiazide

Study type

Interventional

Funder types

Other

Identifiers

NCT00509470

P2007008

Details and patient eligibility

About

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.

Full description

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.

Enrollment

75 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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