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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
telmisartan plus hydrochlorothiazide
Amlodipine
Sponsored by
Tokyo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

telmisartan plus low-dose hydrochlorothiazide

Amlodipine

Arm Description

12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide

Amlodipine is continuously administered.

Outcomes

Primary Outcome Measures

Changes in office blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2007
Last Updated
October 17, 2016
Sponsor
Tokyo University
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1. Study Identification

Unique Protocol Identification Number
NCT00509470
Brief Title
Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine
Acronym
ONEAST
Official Title
ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
telmisartan plus low-dose hydrochlorothiazide
Arm Type
Active Comparator
Arm Description
12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide
Arm Title
Amlodipine
Arm Type
Active Comparator
Arm Description
Amlodipine is continuously administered.
Intervention Type
Drug
Intervention Name(s)
telmisartan plus hydrochlorothiazide
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Amlodipine
Primary Outcome Measure Information:
Title
Changes in office blood pressure
Time Frame
After 12 week treatment
Secondary Outcome Measure Information:
Title
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
Time Frame
After 12 week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiro Fujita, MD, PhD
Organizational Affiliation
Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan

12. IPD Sharing Statement

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

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