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NCT00295555 Clinical Trial

Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

Diabetes Mellitus Clinical Trial

Official title:
Effects of Doxazosin on Ambulatory Blood Pressure and Sympathetic Nervous Activity in Hypertensive Patients With Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00295555
Other study ID # 7332-2
Secondary ID
Status Completed
Phase Phase 4
First received February 21, 2006
Last updated May 8, 2007
Start date January 2004
Est. completion date April 2007

Study information
Verified date April 2007
Source Yokohama City University Medical Center
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Effects of doxazosin on morning surge in diabetic patients

Locations
Country Name City State
Japan Yokohama City University Center Hospital Yokohama

Sponsors (1)
Lead Sponsor Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Yasuda G, Ando D, Hirawa N, Umemura S, Tochikubo O. Effects of losartan and amlodipine on urinary albumin excretion and ambulatory blood pressure in hypertensive type 2 diabetic patients with overt nephropathy. Diabetes Care. 2005 Aug;28(8):1862-8. — View Citation

Yasuda G, Hasegawa K, Kuji T, Ogawa N, Shimura G, Umemura S, Tochikubo O. Effects of doxazosin on ambulatory blood pressure and sympathetic nervous activity in hypertensive Type 2 diabetic patients with overt nephropathy. Diabet Med. 2005 Oct;22(10):1394-400. — View Citation

Yasuda G, Hasegawa K, Kuji T, Ogawa N, Shimura G, Umemura S, Tochikubo O. Perindopril effects on ambulatory blood pressure: relation to sympathetic nervous activity in subjects with diabetic nephropathy. Am J Hypertens. 2004 Jan;17(1):14-20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Normalization of high blood pressure One year
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