NCT00126516

Brief Summary

The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
395

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

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

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

9.1 years

First QC Date

August 3, 2005

Last Update Submit

October 28, 2013

Conditions

Brain InfarctionHypertension

Keywords

silent brain infarctioncognitive declineAngiotensin II Type 1 Receptor BlockersAngiotensin-Converting Enzyme Inhibitorshypertension

Outcome Measures

Primary Outcomes (2)

  • Fatal and nonfatal stroke

    two years

  • Progression of silent brain infarction or white matter lesion on magnetic resonance imaging

    two years

Secondary Outcomes (3)

  • Fatal and nonfatal acute coronary syndrome

    two years

  • Admission for heart failure

    two years

  • All cause mortality

    two years

Study Arms (2)

1

ACTIVE COMPARATOR

Angiotensin II Receptor Antagonists group

Drug: Angiotensin II Receptor Antagonists

2

ACTIVE COMPARATOR

Angiotensin-converting Enzyme Inhibitors group

Drug: Angiotensin-converting Enzyme Inhibitors

Interventions

Angiotensin II Receptor AntagonistsDRUG

any dosage, frequency, and duration

1
Angiotensin-converting Enzyme InhibitorsDRUG

any dosage, frequency, and duration

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with essential hypertension (systolic blood pressure\>=140 mmHg and/or diastolic blood pressure\>=90, or treated with antihypertensive drugs)
  • Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging

You may not qualify if:

  • Secondary hypertension
  • Atrial fibrillation
  • History or signs of cerebral disorders other than cerebrovascular disease
  • Malignant tumor
  • Chronic renal failure
  • Severe congestive heart failure
  • Hyperkalemia
  • Stenosis of bilateral renal artery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Internal Medicine, Nara Medical University

Kashihara, Nara, 634-8522, Japan

Location

MeSH Terms

Conditions

Brain InfarctionHypertensionCognitive Dysfunction

Interventions

Angiotensin Receptor AntagonistsAngiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtease InhibitorsEnzyme Inhibitors

Study Officials

  • Yoshihiko Saito, MD, PhD

    First Department of Internal Medicine, Nara Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 4, 2005

Study Start

May 1, 2004

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

JP(1)