Japan Morning Surge-1 Study

Hypertension Clinical Trial

Official title:

The Effects of Controlling Morning Hypertension on Target Organ Damage With Adrenergic Blockers, Based on Self-Measured Morning Blood Pressure Readings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285519
• Other study ID #: JHF-03-143
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2006
• Last updated: February 1, 2006
• Start date: August 2003
• Est. completion date: August 2005

Study information

• Verified date: February 2006
• Source: Japan Heart Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Doxazosin (drug)

Locations

Country	Name	City	State
Japan	Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine	Shimotsuke	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Japan Heart Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain natriuretic peptide and the urinary albumin excretion/creatinine ratio at 6 months