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...
Date First Received: January 24, 2006
Last Updated: February 1, 2006
Verified by: Japan Heart Foundation, February 2006
Clinical Trial Phase: Phase 4 | Start Date: August 2003
Overall Status: Completed
Estimated Enrollment: 600
Brief Summary
Official Title: “The Effects of Controlling Morning Hypertension on Target Organ Damage With Adrenergic Blockers, Based on Self-Measured Morning Blood Pressure Readings”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Detailed Clinical Trial Description
Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage.We will evaluate whether strict morning blood pressure control by sympathetic nervous system blockade using an alfa-blocker, doxazosin, and with the addition of a beta-blocker if needed, can reduce hypertensive target organ damage.
Intervention(s) in this Clinical Trial
- Drug: Doxazosin (drug)
Outcome Measures for this Clinical Trial
Primary Measures
- brain natriuretic peptide and the urinary albumin excretion/creatinine ratio at 6 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Morning systolic blood pressure >135 mmHg in a sitting position at home while on stable antihypertensive medication for at least 3 months
Exclusion Criteria:
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Japan Heart Foundation
Overall Clinical Trial Officials and Contacts
Kazuomi Kario, MD, PhD Study Chair Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00285519
Study ID Number: JHF-03-143
ClinicalTrials.gov Identifier: NCT00285519
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
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