NCT00790946

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Jun 2006

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 3, 2010

Status Verified

December 1, 2008

Enrollment Period

3.5 years

First QC Date

October 10, 2008

Last Update Submit

June 2, 2010

Conditions

HypertensionObesity

Keywords

valsartanMetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure, Adiponectin and PAI-1 concentration

    1 year

Secondary Outcomes (9)

  • HOMA-IR

    1 year

  • HbA1c

    1 year

  • TNF-α

    １ year

  • IL-6

    1 year

  • BNP

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Valsartan

ACTIVE COMPARATOR

Valsartan 80 to 160mg

Drug: Valsartan

standard therapy

NO INTERVENTION

Interventions

ValsartanDRUG

Valsartan 80 to 160 mg

Valsartan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuwa Tei,MD,FACC,FAHA

Kagoshima, Kagoshima-ken, 890-8520, Japan

RECRUITING

Related Publications (1)

  • 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. doi: 10.1253/circj.cj-12-0153.

    PMID: 22451451DERIVED

MeSH Terms

Conditions

HypertensionObesityMetabolic Syndrome

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Chuwa Tei, MD, PhD

    Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University

    STUDY CHAIR

Central Study Contacts

Chuwa Tei, MD, PhD

CONTACT

tei@m.kufm.kagoshima-u.ac.jp

Masaaki Miyata, MD, PhD

CONTACT

＋81-99-275-5318miyatam@m3.kufm.kagoshima-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2008

First Posted

November 14, 2008

Study Start

June 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 3, 2010

Record last verified: 2008-12

Locations

JP(1)