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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
History of Changes
  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 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:

Drug Information available for: Valsartan
U.S. FDA Resources

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
Other Name: Valsartan
No Intervention: standard therapy

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 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
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

No publications provided by Kagoshima University

Additional 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:
valsartan
Metabolic syndrome

Additional relevant MeSH terms:
Hypertension
Obesity
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013