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Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT00295555
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : May 10, 2007
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Study Description
Brief Summary:
Few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure and regulation of sympathetic nervous activity in hypertensive patients with diabetic nephropathy. Using ambulatory blood pressure monitoring devices equipped with spectral analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in diabetic nephropathy patients and compare the results with those in patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Essential Hypertension Renal Failure Drug: Effects of doxazosin on morning surge in diabetic patients Phase 4

Detailed Description:
The study is an open-labeled parallel prospective trial comparing the effects of doxazosin (2-8 mg/day) on 24-h blood pressure and autonomic nervous activity. Hypertensive patients with non-insulin-dependent diabetic nephropathy, patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy undergo ambulatory blood pressure monitoring before and after treatment with doxazosin. Simultaneously, spectral analysis is performed to calculate the high frequency components as a marker of parasympathetic nervous activity, and the low frequency components/high frequency components ratios as an index of the sympathovagal balance.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Doxazosin on Ambulatory Blood Pressure and Sympathetic Nervous Activity in Hypertensive Patients With Diabetic Nephropathy
Study Start Date : January 2004
Study Completion Date : April 2007

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Normalization of high blood pressure [ Time Frame: One year ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypertensive patients with diabetes mellitus
  • Hypertensive patients
  • Hypertensive patients with renal disease

Exclusion Criteria:

  • Cardiac, hematologic or hepatic disease
  • Renal insufficiency (serum creatinine values> 2 mg/L)
  • Hormone-induced hypertension
  • Cerebral infarction or hemorrhage
  • Other major diseases
Contacts and Locations

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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): NCT00295555

Yokohama City University Center Hospital
Yokohama, Japan, 232-0024
Sponsors and Collaborators
Yokohama City University Medical Center
Principal Investigator: Gen Yasuda, MD Yokohama City University Center Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00295555     History of Changes
Other Study ID Numbers: 7332-2
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: May 10, 2007
Last Verified: April 2007

Keywords provided by Yokohama City University Medical Center:
ambulatory blood pressure monitoring
alpha1-adrenergic antagonists
sympathetic nervous activity
diabetic nephropathy
essential hypertension
power spectral analysis
morning surge

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency
Diabetic Nephropathies
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
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