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Japan Morning Surge-1 Study

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00285519

First Posted: February 2, 2006

Last Update Posted: February 2, 2006

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Japan Heart Foundation

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Doxazosin (drug)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	The Effects of Controlling Morning Hypertension on Target Organ Damage With Adrenergic Blockers, Based on Self-Measured Morning Blood Pressure Readings

Resource links provided by NLM:

Drug Information available for: Doxazosin Doxazosin mesylate

U.S. FDA Resources

Further study details as provided by Japan Heart Foundation:

Primary Outcome Measures:

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


Estimated Enrollment:	600
Study Start Date:	August 2003
Estimated Study Completion Date:	August 2005

Detailed 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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285519

Locations


Japan
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Shimotsuke, Tochigi, Japan, 329-0498

Sponsors and Collaborators

Japan Heart Foundation

Investigators


Study Chair:	Kazuomi Kario, MD, PhD	Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00285519 History of Changes
Other Study ID Numbers:	JHF-03-143
First Submitted:	January 24, 2006
First Posted:	February 2, 2006
Last Update Posted:	February 2, 2006
Last Verified:	February 2006

Keywords provided by Japan Heart Foundation:


Morning hypertension

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Doxazosin Antihypertensive Agents Adrenergic alpha-1 Receptor Antagonists	Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

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