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

NCT ID: NCT00509470

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-10-31

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

telmisartan plus low-dose hydrochlorothiazide

12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide

Group Type: ACTIVE_COMPARATOR

telmisartan plus hydrochlorothiazide

Intervention Type: 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

Amlodipine is continuously administered.

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DEVICE

Interventions

telmisartan plus hydrochlorothiazide

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

Intervention Type: DRUG

Amlodipine

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo University

OTHER

Sponsor Role: lead

Responsible Party

Hiroshi Satonaka

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Toshiro Fujita, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tokyo, , Japan

Countries

Japan

Other Identifiers

P2007008

Identifier Type: -

Identifier Source: org_study_id