Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

• Sponsor: Kagoshima University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00790946
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 5.9

Study Details

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
• Anticipated 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: Jun 1, 2006
• Anticipated Primary Completion Date: Dec 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

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 [1 year]

Secondary Outcome Measures

1. HOMA-IR [1 year]

2. HbA1c [1 year]

3. TNF-α [１ year]

4. IL-6 [1 year]

5. BNP [1 year]

6. LVMI [1 year]

7. E/A ratio [1 year]

8. Tei-index [1 year]

9. Apo-J [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Chuwa Tei,MD,FACC,FAHA	Kagoshima		Japan	890-8520

Sponsors and Collaborators

• Kagoshima University

Investigators

• Study Chair: Chuwa Tei, MD, PhD, Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00790946
• Other Study ID Numbers: CVM-RCT-2006-06
• First Posted: Nov 14, 2008
• Last Update Posted: Jun 3, 2010
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: valsartan; Metabolic syndrome
• Additional relevant MeSH terms: Hypertension; Metabolic Syndrome; Valsartan

Study Results

No Results Posted as of Jun 3, 2010