Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine
Information source: Tokyo University
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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
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.
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
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
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