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

ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00509470

Acronym

ONEAST

Enrollment

Registered

2007-07-31

Start date

2007-07-31

Completion date

2012-10-31

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief 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.

Detailed 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.

Interventions

DRUGtelmisartan plus hydrochlorothiazide

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

DEVICEAmlodipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Changes in office blood pressure	After 12 week treatment

Secondary

Measure	Time frame
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	After 12 week treatment

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026