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

Essential Hypertension Clinical Trial

— ONEAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509470
• Other study ID #: P2007008
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2007
• Last updated: October 17, 2016
• Start date: July 2007
• Est. completion date: October 2012

Study information

• Verified date: October 2016
• Source: Tokyo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• 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

Device:
• Amlodipine

Locations

Country	Name	City	State
Japan	Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in office blood pressure		After 12 week treatment	No
Secondary	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	No