- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00509470
Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine (ONEAST)
October 17, 2016 updated by: Hiroshi Satonaka, Tokyo University
ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 113-8655
- Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: telmisartan plus low-dose hydrochlorothiazide
12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide
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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
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Active Comparator: Amlodipine
Amlodipine is continuously administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in office blood pressure
Time Frame: After 12 week treatment
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After 12 week treatment
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Secondary Outcome Measures
Outcome 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
Time Frame: After 12 week treatment
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After 12 week treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Toshiro Fujita, MD, PhD, Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
July 28, 2007
First Submitted That Met QC Criteria
July 28, 2007
First Posted (Estimate)
July 31, 2007
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 17, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Amlodipine
- Hydrochlorothiazide
- Telmisartan
Other Study ID Numbers
- P2007008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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