Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Japan Morning Surge-1 Study

This study has been completed.
Sponsor:
Information provided by:
Japan Heart Foundation
ClinicalTrials.gov Identifier:
NCT00285519
First received: January 24, 2006
Last updated: February 1, 2006
Last verified: February 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Japan Heart Foundation

Additional 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
Study First Received: January 24, 2006
Last Updated: February 1, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Heart Foundation:
Morning hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015