NCT00295555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 10, 2007

Status Verified

April 1, 2007

First QC Date

February 21, 2006

Last Update Submit

May 8, 2007

Conditions

Diabetes MellitusEssential HypertensionRenal Failure

Keywords

ambulatory blood pressure monitoringdoxazosinalpha1-adrenergic antagonistssympathetic nervous activitydiabetic nephropathyessential hypertensionpower spectral analysismorning surge

Outcome Measures

Primary Outcomes (1)

  • Normalization of high blood pressure

    One year

Interventions

Effects of doxazosin on morning surge in diabetic patientsDRUG

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Center Hospital

Yokohama, 232-0024, Japan

Location

Related Publications (4)

  • 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. doi: 10.1111/j.1464-5491.2005.01636.x.

    PMID: 16176202BACKGROUND

  • 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. doi: 10.2337/diacare.28.8.1862.

    PMID: 16043724BACKGROUND

  • 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. doi: 10.1016/j.amjhyper.2003.08.005.

    PMID: 14700506BACKGROUND

  • Yasuda G, Saka S, Ando D, Hirawa N. Effects of doxazosin as the third agent on morning hypertension and position-related blood pressure changes in diabetic patients with chronic kidney disease. Clin Exp Hypertens. 2015;37(1):75-81. doi: 10.3109/10641963.2014.913599. Epub 2014 May 27.

    PMID: 24866870DERIVED

MeSH Terms

Conditions

Diabetes MellitusEssential HypertensionRenal InsufficiencyDiabetic Nephropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHypertensionVascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Study Officials

  • Gen Yasuda, MD

    Yokohama City University Center Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Study Start

January 1, 2004

Study Completion

April 1, 2007

Last Updated

May 10, 2007

Record last verified: 2007-04

Locations

JP(1)