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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000778

Enrollment

Registered

2007-07-26

Start date

2007-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

essential hypertension

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 5 mg/day of amlodipine is administered for more than 3 months 2) Systolic or diastolic blood pressure >= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study) 3) Outpatients

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Changes in office blood pressure	—

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)	—

Countries

Japan

Contacts

Public ContactKatsuyuki Ando

University of Tokyo Graduate School of Medicine Department of Nephrology and Endocrinology

katsua-tky@umin.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026