Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study) - Full Text View

Sponsored by:	Kagoshima University
Information provided by:	Kagoshima University
ClinicalTrials.gov Identifier:	NCT00790946

Purpose

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.

Condition	Intervention	Phase
Hypertension Obesity	Drug: Valsartan	Phase IV

MedlinePlus related topics: High Blood Pressure Obesity Obesity in Children

Drug Information available for: Valsartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

Further study details as provided by Kagoshima University:

Primary Outcome Measures:

Blood Pressure, Adiponectin and PAI-1 concentration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HOMA-IR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
TNF-α [ Time Frame: １ year ] [ Designated as safety issue: Yes ]
IL-6 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
BNP [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
LVMI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
E/A ratio [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Tei-index [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Apo-J [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	June 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Valsartan: Active Comparator Valsartan 80 to 160mg	Drug: Valsartan Valsartan 80 to 160 mg
standard therapy: No Intervention

Detailed 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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 hight 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790946

Contacts

Contact: Chuwa Tei, MD, PhD		tei@m.kufm.kagoshima-u.ac.jp
Contact: Masaaki Miyata, MD, PhD	＋81-99-275-5318	miyatam@m3.kufm.kagoshima-u.ac.jp

Locations

Japan
Chuwa Tei,MD,FACC,FAHA	Recruiting
kagoshima, Japan, 890-8520
Contact: Chuwa Tei, MD,FACC,FAHA tei@m.kufm.kagoshima-u.ac.jp
Contact: Masaaki Miyata, MD,PhD、FACC miyatam@m3.kufm.kagoshima-u.ac.jp

Sponsors and Collaborators

Kagoshima University

Investigators

Study Chair:

Chuwa Tei, MD, PhD

Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University

More Information

Responsible Party:	Kagoshima University ( Chuwa Tei / Professor )
Study ID Numbers:	CVM-RCT-2006-06
Study First Received:	October 10, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00790946
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kagoshima University:

valsartan
Metabolic syndrome

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Vascular Diseases
Nutrition Disorders

Overweight
Overnutrition
Valsartan
Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Disease
Therapeutic Uses
Syndrome

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009