Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

Kagoshima University

Status and phase

Unknown

Phase 4

Conditions

Hypertension

Obesity

Treatments

Drug: Valsartan

Study type

Interventional

Funder types

Other

Identifiers

NCT00790946

CVM-RCT-2006-06

Details and patient eligibility

About

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.

Full description

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

Enrollment

250 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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