NCT00460213

Brief Summary

The purpose of this study is to compare improvement percentage of urinary albumin excretion between valsartan 80 mg- and valsartan 160 mg-based therapy in patient with morning hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_4 hypertension

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

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

2.4 years

First QC Date

March 28, 2007

Last Update Submit

December 5, 2013

Conditions

Hypertension

Keywords

home blood pressure

Outcome Measures

Primary Outcomes (1)

  • Improvement percentage of urinary albumin excretion

    3, 6, 9, and 12 months

Secondary Outcomes (1)

  • home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy

    every month

Study Arms (1)

Valsartan

EXPERIMENTAL
Drug: Valsartan 80mg dailyDrug: Valsartan 160mg daily

Interventions

Valsartan 80mg dailyDRUG
Valsartan
Valsartan 160mg dailyDRUG
Valsartan

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients aged over 20 years and less than 80 years, regardless of sex.
  • Patients with stable seated morning home blood pressure of over 135 mmHg and/or diastolic blood pressure of over 85 mmHg within 1 to 2 weeks.
  • Patients who are on therapy with conventional dosage of ARB.

You may not qualify if:

  • Patients who are difficult to measure home blood pressure.
  • Patients with secondary hypertension or malignant hypertension.
  • Patients with seated systolic blood pressure of over 200 mmHg.
  • Patients with seated diastolic blood pressure of over 120 mmHg.
  • Patients with a history of cerebrovascular disorder or myocardial infarction or heart failure within 6 months prior to enrolment in the study.
  • Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
  • Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
  • Patients with serious liver dysfunction.
  • Patient with HbA1C of over 8 percent.
  • Patient with positive albuminuria by dip and read stick test.
  • Patient treated with any angiotensin converting enzyme inhibitor
  • Pregnant women
  • Patients with a history of hypersensitivity to valsartan.
  • Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koshiro Fukiyama

Kitakyushu, Fukuoka, 808-0024, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Koshiro Fukiyama, MD

    Japan Seamen's Relief Association Moji Hospital

    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
Honorary Director

Study Record Dates

First Submitted

March 28, 2007

First Posted

April 13, 2007

Study Start

July 1, 2006

Primary Completion

December 1, 2008

Study Completion

November 1, 2013

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

JP(1)