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Japan Morning Surge-1 Study

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. Identifier: NCT00285519
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : February 2, 2006
Information provided by:
Japan Heart Foundation

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Doxazosin (drug) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
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
Study Start Date : August 2003
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. brain natriuretic peptide and the urinary albumin excretion/creatinine ratio at 6 months

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00285519

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Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Shimotsuke, Tochigi, Japan, 329-0498
Sponsors and Collaborators
Japan Heart Foundation
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Study Chair: Kazuomi Kario, MD, PhD Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00285519    
Other Study ID Numbers: JHF-03-143
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: February 2, 2006
Last Verified: February 2006
Keywords provided by Japan Heart Foundation:
Morning hypertension
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
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