Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by Yokohama City University Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Yokohama City University Medical Center

ClinicalTrials.gov Identifier:

NCT00492128

First received: June 26, 2007

Last updated: June 24, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 26, 2007

Last Updated Date

June 24, 2010

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

The change of systolic blood pressure [ Time Frame: three months ]

Change History

Complete list of historical versions of study NCT00492128 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

Official Title ^ICMJE

Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Losartan/amlodipine or losartan/hydrochlorothiazide

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)

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

August 2010

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Satoshi Umemura, MD, PhD

81-45-787-2635

umemuras@med.yokohama-cu.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00492128

Other Study ID Numbers ^ICMJE

200706001

Has Data Monitoring Committee

Responsible Party

Yokohama City University Medical Center, Department of Medical Science and Cardiorenal

Study Sponsor ^ICMJE

Yokohama City University Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Satoshi Umemura, MD, PhD

Yokohama City University Graduate School of Medicine

Information Provided By

Yokohama City University Medical Center

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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