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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790946
First Posted: November 14, 2008
Last Update Posted: June 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kagoshima University
October 10, 2008
November 14, 2008
June 3, 2010
June 2006
December 2009   (Final data collection date for primary outcome measure)
Blood Pressure, Adiponectin and PAI-1 concentration [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00790946 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)
Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

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.

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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Hypertension
  • Obesity
Drug: Valsartan
Valsartan 80 to 160 mg
  • Active Comparator: Valsartan
    Valsartan 80 to 160mg
    Intervention: Drug: Valsartan
  • No Intervention: standard therapy
Miyata M, Ikeda Y, Nakamura S, Sasaki T, Abe S, Minagoe S, Torii H, Lee S, Tateishi S, Kihara K, Ohba I, Kajiya S, Furusho Y, Hamasaki S, Tei C; Kagoshima Collaborate Trial in Metabolic Syndrome (KACT-MetS) Investigators. Effects of valsartan on fibrinolysis in hypertensive patients with metabolic syndrome. Circ J. 2012;76(4):843-51.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
250
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00790946
CVM-RCT-2006-06
Yes
Not Provided
Not Provided
Chuwa Tei / Professor, Kagoshima University
Kagoshima University
Not Provided
Study Chair: Chuwa Tei, MD, PhD Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University
Kagoshima University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP