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

Phase 4

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: telmisartan plus hydrochlorothiazide; Device: Amlodipine

• Registration Number: NCT00509470
• Lead Sponsor: Tokyo University

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-28
• Study First Submitted QC: 2007-07-28
• Study First Posted: 2007-07-31
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telmisartan plus low-dose hydrochlorothiazide	telmisartan plus hydrochlorothiazide	12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide
Amlodipine	Amlodipine	Amlodipine is continuously administered.

Primary Outcome Measures

Name	Time	Method
Changes in office blood pressure	After 12 week treatment

Secondary Outcome Measures

Name	Time	Method
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	After 12 week treatment

Trial Locations

Locations (1)

Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine; 🇯🇵 Tokyo, Japan