Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine - Full Text View

Sponsor:	Tokyo University
Information provided by:	Tokyo University
ClinicalTrials.gov Identifier:	NCT00509470

Purpose

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.

Condition	Intervention	Phase
Essential Hypertension	Drug: telmisartan plus hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Telmisartan

U.S. FDA Resources

Further study details as provided by Tokyo University:

Primary Outcome Measures:

Changes in office blood pressure [ Time Frame: After 12 week treatment ]

Secondary Outcome Measures:

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 [ Time Frame: After 12 week treatment ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
A: Active Comparator Amlodipine (5 mg/day) is continuously administered. If blood pressure is not reach to lower than 140/90 mmHg, amlodipine can be increased to 7.5 mg/day.	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

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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509470

Contacts

Contact: Katsuyuki Ando, MD, PhD

+81-3-5800-9119

katsua-tky@umin.ac.jp

Locations

Japan
Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine	Recruiting
Tokyo, Japan, 113-8655
Contact: Katsuyuki Ando, MD, PhD +81-3-5800-9119 katsua-tky@umin.ac.jp

Sponsors and Collaborators

Tokyo University

Investigators

Principal Investigator:

Toshiro Fujita, MD, PhD

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

More Information

No publications provided

Study ID Numbers:	P2007008
Study First Received:	July 28, 2007
Last Updated:	July 28, 2007
ClinicalTrials.gov Identifier:	NCT00509470 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009