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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Kagoshima University.
Recruitment status was:  Recruiting
Information provided by:
Kagoshima University 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
Hypertension Obesity Drug: Valsartan Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • HOMA-IR [ Time Frame: 1 year ]
  • HbA1c [ Time Frame: 1 year ]
  • TNF-α [ Time Frame: 1 year ]
  • IL-6 [ Time Frame: 1 year ]
  • BNP [ Time Frame: 1 year ]
  • LVMI [ Time Frame: 1 year ]
  • E/A ratio [ Time Frame: 1 year ]
  • Tei-index [ Time Frame: 1 year ]
  • Apo-J [ Time Frame: 1 year ]

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 identifier: NCT00790946

Contact: Chuwa Tei, MD, PhD
Contact: Masaaki Miyata, MD, PhD +81-99-275-5318

Chuwa Tei,MD,FACC,FAHA Recruiting
Kagoshima, Japan, 890-8520
Contact: Chuwa Tei, MD,FACC,FAHA   
Contact: Masaaki Miyata, MD,PhD、FACC   
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 Identifier (NCT Number):
Responsible Party: Chuwa Tei / Professor, Kagoshima University Identifier: NCT00790946     History of Changes
Other Study ID Numbers: CVM-RCT-2006-06
Study First Received: October 10, 2008
Last Updated: June 2, 2010

Keywords provided by Kagoshima University:
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017