NCT00140790

Brief Summary

The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

8.6 years

First QC Date

August 31, 2005

Last Update Submit

February 25, 2016

Conditions

Hypertension

Keywords

Cardiorenal syndromeRenal dysfunctionCardiovascular eventsValsartan

Outcome Measures

Primary Outcomes (3)

  • Cardiovascular events

    2 years

  • End-stage renal dysfunction

    2 years

  • 50% reduction of creatinine clearance

    2 years

Secondary Outcomes (9)

  • % FS and E/A ratio

    2 years

  • Specific biochemical markers for cardiac or renal function

    6 months and 1 year and 2 years

  • % changes of creatinine clearance

    2 years

  • 1/(serum Cr)

    2 years

  • Serum K

    2 years

  • +4 more secondary outcomes

Study Arms (2)

Valsartan 40mg

ACTIVE COMPARATOR

Standard Dose valsartan

Drug: valsartan

Valsartan 160mg

ACTIVE COMPARATOR

High Dose valsartan

Drug: valsartan

Interventions

valsartanDRUG

valsartan 40 or 160 (80) mg per day

Valsartan 160mgValsartan 40mg

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systolic blood pressure (SBP) \>/= 140 and/or diastolic blood pressure (DBP) \>/= 90 (untreated hypertension cases); or SBP\>/=130 and/or DBP\>/=80 (treated hypertension cases)
  • Patients with coronary artery disease (more than 50% stenosis on coronary angiography \[CAG\], coronary computed tomography \[CT\] or coronary magnetic resonance angiography \[MRA\]; coronary spasm; or history of percutaneous coronary intervention \[PCI\]);Unstable angina patient
  • Creatinine clearance between 30.0 and 89.9 ml/min

You may not qualify if:

  • Reduced left ventricular (LV) function (ejection fraction \[EF\] equal to or less than 40%)
  • Hyperpotassemia (serum potassium equal to or more than 5.5 mEq/l)
  • Rapid progressive glomerular nephritis
  • Nephrotic syndrome
  • Renal artery stenosis
  • Uncontrolled diabetes (HbA1c equal to or more than 9.0%)
  • History of allergy to valsartan
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Cardiovascular Medicine, Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Kumamoto, 860-8556, Japan

Location

MeSH Terms

Conditions

HypertensionCardio-Renal SyndromeRenal Insufficiency

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Hisao Ogawa, MD, PhD

    Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

August 1, 2006

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

JP(2)