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

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.
ClinicalTrials.gov Identifier: NCT00790946
Recruitment Status : Unknown
Verified December 2008 by Kagoshima University.
Recruitment status was:  Recruiting
First Posted : November 14, 2008
Last Update Posted : June 3, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Obesity Drug: Valsartan Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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
Study Start Date : June 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Valsartan
Valsartan 80 to 160mg
Drug: Valsartan
Valsartan 80 to 160 mg
No Intervention: standard therapy


Outcome Measures

Primary Outcome Measures :
  1. Blood Pressure, Adiponectin and PAI-1 concentration [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. HOMA-IR [ Time Frame: 1 year ]
  2. HbA1c [ Time Frame: 1 year ]
  3. TNF-α [ Time Frame: 1 year ]
  4. IL-6 [ Time Frame: 1 year ]
  5. BNP [ Time Frame: 1 year ]
  6. LVMI [ Time Frame: 1 year ]
  7. E/A ratio [ Time Frame: 1 year ]
  8. Tei-index [ Time Frame: 1 year ]
  9. Apo-J [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: December 2008

Keywords provided by Kagoshima University:
valsartan
Metabolic syndrome

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