Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.

* Blood pressure control
* Changing of adiponectin and plasminogen activator inhibitor-1
* Influence metabolizing and cardiac function, etc.

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Detailed Description

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The primary endpoints are:

* blood pressure control
* Adiponectin and plasma type1 plasminogen active inhibitor

The secondary endpoints are

* HOMA-IR
* HbA1c
* TNF-α
* IL-6
* Plasma B-type natriuretic peptide
* LVMI
* E/A ratio
* Tei-index
* Apo-J

Conditions

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Hypertension Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Valsartan

Valsartan 80 to 160mg

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

Valsartan 80 to 160 mg

standard therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Valsartan

Valsartan 80 to 160 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Out patients with hypertension male and female
* Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
* Waist Surrounding diameter male≧85cm female≧90cm
* Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
* Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol \< 40 mg/dl or fasting blood glucose ≧110 mg/dl
* Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB

Exclusion Criteria

* Patient who is using ACE-I and ARB
* Serum creatinine ≧ 3 mg/dl
* Liver impairment
* History of allergy to valsartan
* Pregnant women
* Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety

Eligible Sex

ALL

Accepts Healthy Volunteers

No