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

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ClinicalTrials.gov Identifier: NCT00509470
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Hiroshi Satonaka, Tokyo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: telmisartan plus hydrochlorothiazide Device: Amlodipine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: telmisartan plus low-dose hydrochlorothiazide
12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide
 Drug: telmisartan 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
Active Comparator: Amlodipine
Amlodipine is continuously administered.
 Device: Amlodipine


Outcome Measures
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Primary Outcome Measures :
  1. Changes in office blood pressure [ Time Frame: After 12 week treatment ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509470


Locations
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Japan
Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Tokyo, Japan, 113-8655
Sponsors and Collaborators
Tokyo University
Investigators
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Principal Investigator: Toshiro Fujita, MD, PhD Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
More Information
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Responsible Party: Hiroshi Satonaka, Professor, Tokyo University
ClinicalTrials.gov Identifier: NCT00509470    
Other Study ID Numbers: P2007008
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists