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

Information source: Tokyo University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: telmisartan plus hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Tokyo University

Official(s) and/or principal investigator(s):
Toshiro Fujita, MD, PhD, Principal Investigator, Affiliation: Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine

Overall contact:
Katsuyuki Ando, MD, PhD, Phone: +81-3-5800-9119, Email: katsua-tky@umin.ac.jp


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes in office blood pressure

Secondary outcome: 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

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.


Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

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

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

Starting date: July 2007
Last updated: July 28, 2007

Page last updated: August 23, 2015

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