NCT00285519

Brief Summary

The purpose of this study is to examine whether strict blood pressure (BP) control by doxazosin using home BP monitoring, especially targeting the morning BP level, can reduce hypertensive target organ damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Aug 2003

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

August 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
Last Updated

February 2, 2006

Status Verified

February 1, 2006

First QC Date

January 24, 2006

Last Update Submit

February 1, 2006

Conditions

Hypertension

Keywords

Morning hypertension

Outcome Measures

Primary Outcomes (1)

  • brain natriuretic peptide and the urinary albumin excretion/creatinine ratio at 6 months

Interventions

Doxazosin (drug)DRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Morning systolic blood pressure \>135 mmHg in a sitting position at home while on stable antihypertensive medication for at least 3 months

You may not qualify if:

  • History of heart failure
  • Presence of orthostatic hypotension, dementia, malignancy and chronic inflammatory disease
  • Taking an alfa-blocker or beta-blocker
  • Atrial fibrillation or atrial flutter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine

Shimotsuke, Tochigi, 329-0498, Japan

Location

Related Publications (1)

  • Hoshide S, Parati G, Matsui Y, Shibazaki S, Eguchi K, Kario K. Orthostatic hypertension: home blood pressure monitoring for detection and assessment of treatment with doxazosin. Hypertens Res. 2012 Jan;35(1):100-6. doi: 10.1038/hr.2011.156. Epub 2011 Sep 15.

    PMID: 21918522DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

DoxazosinPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PrazosinQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kazuomi Kario, MD, PhD

    Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical 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

Study Record Dates

First Submitted

January 24, 2006

First Posted

February 2, 2006

Study Start

August 1, 2003

Study Completion

August 1, 2005

Last Updated

February 2, 2006

Record last verified: 2006-02

Locations

JP(1)