Clinical trial NCT00509470: Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: Tokyo University
Sponsor class: OTHER
First posted: 2007-07-31
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Changes in office blood pressure
timeFrame: After 12 week treatment
Secondary outcomes:
measure: 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
timeFrame: After 12 week treatment
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Study officials:
affiliation: Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
name: Toshiro Fujita, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: