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Japan Morning Surge-1 Study

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

Study Description
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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.

Study Design
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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

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U.S. FDA Resources

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

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

ClinicalTrials.gov Identifier: NCT00285519     History of Changes
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:
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