Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study) (KACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Kagoshima University.
Recruitment status was  Recruiting
Information provided by:
Kagoshima University
ClinicalTrials.gov Identifier:
First received: October 10, 2008
Last updated: June 2, 2010
Last verified: December 2008

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
Drug: Valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

Resource links provided by NLM:

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: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Valsartan
Valsartan 80 to 160mg
Drug: Valsartan
Valsartan 80 to 160 mg
No Intervention: standard therapy

Detailed Description:

The primary endpoints are:

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

The secondary endpoints are

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Study Chair: Chuwa Tei, MD, PhD Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chuwa Tei / Professor, Kagoshima University
ClinicalTrials.gov Identifier: NCT00790946     History of Changes
Other Study ID Numbers: CVM-RCT-2006-06 
Study First Received: October 10, 2008
Last Updated: June 2, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kagoshima University:
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Cardiovascular Diseases
Glucose Metabolism Disorders
Insulin Resistance
Metabolic Diseases
Vascular Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 30, 2016