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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hiroshi Satonaka, Tokyo University
ClinicalTrials.gov Identifier:
NCT00509470
First received: July 28, 2007
Last updated: October 17, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Essential Hypertension
Drug: telmisartan plus hydrochlorothiazide
Device: Amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tokyo University:

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

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 [ Time Frame: After 12 week treatment ]

Enrollment: 75
Study Start Date: July 2007
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509470

Locations
Japan
Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Tokyo, Japan, 113-8655
Sponsors and Collaborators
Tokyo University
Investigators
Principal Investigator: Toshiro Fujita, MD, PhD Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
  More Information

Responsible Party: Hiroshi Satonaka, Professor, Tokyo University
ClinicalTrials.gov Identifier: NCT00509470     History of Changes
Other Study ID Numbers: P2007008 
Study First Received: July 28, 2007
Last Updated: October 17, 2016

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Amlodipine
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 23, 2017