Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492128
• Other study ID #: 200706001
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2007
• Last updated: January 28, 2015
• Start date: September 2007
• Est. completion date: August 2010

Study information

• Verified date: January 2015
• Source: Yokohama City University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: August 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Japan	Yokohama City University Graduate School of Medicine	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of systolic blood pressure		three months	Yes
Secondary	The achievement rate of target blood pressure		three months	Yes
Secondary	The change of diastolic blood pressure		three months	Yes
Secondary	The change of blood pressure		six months, nine months and one year	Yes
Secondary	The achievement rate of target blood pressure		six months, nine months and one year	Yes