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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Tokyo University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00509470
First received: July 28, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ]

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Active Comparator: A
Amlodipine (5 mg/day) is continuously administered. If blood pressure is not reach to lower than 140/90 mmHg, amlodipine can be increased to 7.5 mg/day.
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

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
Genders Eligible for Study:   Both
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

Contacts
Contact: Katsuyuki Ando, MD, PhD +81-3-5800-9119 katsua-tky@umin.ac.jp

Locations
Japan
Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine Recruiting
Tokyo, Japan, 113-8655
Contact: Katsuyuki Ando, MD, PhD    +81-3-5800-9119    katsua-tky@umin.ac.jp   
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

No publications provided

ClinicalTrials.gov Identifier: NCT00509470     History of Changes
Other Study ID Numbers: P2007008
Study First Received: July 28, 2007
Last Updated: July 28, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 29, 2014