Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

Obesity Clinical Trial

— KACT  

Official title:

Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00790946
• Other study ID #: CVM-RCT-2006-06
• Status: Recruiting
• Phase: Phase 4
• First received: October 10, 2008
• Last updated: June 2, 2010
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2008
• Source: Kagoshima University
• Contact: Chuwa Tei, MD, PhD
• Email: tei[@]m.kufm.kagoshima-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome X
• Obesity

Intervention

Drug:
• Valsartan
Valsartan 80 to 160 mg

Locations

Country	Name	City	State
Japan	Chuwa Tei,MD,FACC,FAHA	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
Kagoshima University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure, Adiponectin and PAI-1 concentration		1 year	Yes
Secondary	HOMA-IR		1 year	Yes
Secondary	HbA1c		1 year	Yes
Secondary	TNF-a		1 year	Yes
Secondary	IL-6		1 year	Yes
Secondary	BNP		1 year	Yes
Secondary	LVMI		1 year	Yes
Secondary	E/A ratio		1 year	Yes
Secondary	Tei-index		1 year	Yes
Secondary	Apo-J		1 year	Yes