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Completed

NCT Number: NCT00509470

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Tokyo, 113-8655, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telmisartan plus hydrochlorothiazide

Drug

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

Amlodipine

Device

Primary outcomes

  1. Changes in office blood pressure

    Time frame: After 12 week treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tokyo University

Other

Registry information

Official study 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

Acronym: ONEAST

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2007
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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