Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

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
Sponsor:
Information provided by:
Kagoshima University
ClinicalTrials.gov Identifier:
NCT00790946
First received: October 10, 2008
Last updated: June 2, 2010
Last verified: December 2008

October 10, 2008
June 2, 2010
June 2006
December 2009   (final data collection date for primary outcome measure)
Blood Pressure, Adiponectin and PAI-1 concentration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00790946 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hypertension
  • Obesity
Drug: Valsartan
Valsartan 80 to 160 mg
Other Name: Valsartan
  • 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.
 
Recruiting
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
Both
Not Provided
No
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
Japan
 
NCT00790946
CVM-RCT-2006-06
Yes
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