NCT00190580

Brief Summary

The purpose of this study is to prove the hypothesis that the progression of renal and cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker valsartan is added to conventional antihypertensive therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2009

Enrollment Period

5.2 years

First QC Date

September 11, 2005

Last Update Submit

March 30, 2015

Conditions

Chronic Kidney DiseaseHypertension

Keywords

CKDchronic kidney diseasehypertensionangiotensin II receptor blockercardiovascular diseasevalsartanKVT

Outcome Measures

Primary Outcomes (1)

  • Course of renal and cardiac function

    every month for renal function and every year for cardiac function

Secondary Outcomes (8)

  • Doubling of serum creatinine concentration

    every month

  • End-stage renal disease

    anytime when it occurs.

  • Myocardial infarction

    anytime when it occurs.

  • Coronary revascularization

    anytime when it occurs.

  • Stroke

    anytime when it occurs

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: valsartanDrug: Conventional antihypertensive drugs

2

EXPERIMENTAL
Drug: Conventional antihypertensive drugs

Interventions

valsartanDRUG

valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs

Also known as: Diovan 40mg or Diovan 80mg
1
Conventional antihypertensive drugsDRUG

Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers

Also known as: any antihypertensive drug except ARB
12

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD with serum creatinine more than 2.0 mg/dl
  • Blood pressure more than 130/85 mmHg
  • years old or above

You may not qualify if:

  • End-stage renal disease with maintenance dialysis
  • Polycystic kidney disease
  • Collagen disease
  • Malignant or accelerated hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Marianna University School of Medicine

Kawasaki, Kanagawa, 216-8511, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertensionCardiovascular Diseases

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kenjiro Kimura, MD, PhD

    St. Marianna University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of St. Marianna University School of Medicine

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

February 1, 2003

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 31, 2015

Record last verified: 2009-03

Locations

JP(1)