Kanagawa Combination Anti-hypertensive Therapy (K-CAT) - Full Text View

Sponsor:	Yokohama City University Medical Center
Information provided by:	Yokohama City University Medical Center
ClinicalTrials.gov Identifier:	NCT00492128

Purpose

The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

Condition	Intervention	Phase
Hypertension	Drug: Losartan/amlodipine or losartan/hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:

The change of systolic blood pressure [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The achievement rate of target blood pressure [ Time Frame: three months ] [ Designated as safety issue: Yes ]
The change of diastolic blood pressure [ Time Frame: three months ] [ Designated as safety issue: Yes ]
The change of blood pressure [ Time Frame: six months, nine months and one year ] [ Designated as safety issue: Yes ]
The achievement rate of target blood pressure [ Time Frame: six months, nine months and one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.

Other Name: Preminent (Hyzaar)

Detailed Description:

The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Under treatment of hypertension with ARB monotherapy for more than one month.
systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position.
In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position.

Exclusion Criteria:

uncontrolled hypertension (diastolic blood pressure >120mmHg)
uncontrolled diabetes mellitus (HbA1c>9.0%)
Acute myocardial infarction, stroke and other cardiovascular events within six months
The history of gout, or uric acid>8.0mg/dl
Serum creatinine>2.0mg/dl
sever liver dysfunction
Bilateral renovascular stenosis
secondary hypertension
malignant hypertension
uncontrolled arrhythmia
pregnancy or possibility of pregnancy
hypersensitivity to trial drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492128

Contacts

Contact: Satoshi Umemura, MD, PhD

81-45-787-2635

umemuras@med.yokohama-cu.ac.jp

Locations

Japan
Yokohama City University Graduate School of Medicine	Recruiting
Yokohama, Kanagawa, Japan, 236-0004

Sponsors and Collaborators

Yokohama City University Medical Center

Investigators

Study Chair:

Satoshi Umemura, MD, PhD

Yokohama City University Graduate School of Medicine

More Information

No publications provided

Responsible Party:	Yokohama City University Medical Center, Department of Medical Science and Cardiorenal
ClinicalTrials.gov Identifier:	NCT00492128 History of Changes
Other Study ID Numbers:	200706001
Study First Received:	June 26, 2007
Last Updated:	June 24, 2010
Health Authority:	Japan: Institutional Review Board

Keywords provided by Yokohama City University Medical Center:

hypertension
angiotensin receptor blocker
diuretic
combination therapy

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Amlodipine
Losartan
Diuretics
Angiotensin Receptor Antagonists
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on February 09, 2012