NCT00409903

Brief Summary

We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in healthy individuals - during baseline conditions and after activation of the sympathetic nervous system.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4 healthy

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

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
Last Updated

September 14, 2007

Status Verified

September 1, 2007

First QC Date

December 10, 2006

Last Update Submit

September 13, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Heart rate

  • Fractional sodium excretion

  • Plasma levels of noradrenaline

Interventions

EprosartanDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders.
  • Age 18 - 65 years.
  • Body mass index less or equal to 30 kg/m2.
  • Women must use oral hormonal anticonception, use intrauterine anticonceptive device, be sterilized/hysterectomized or be postmenopausal.

You may not qualify if:

  • History or clinical signs of heart, lung, kidney, or endocrine organ disease.
  • Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
  • Abnormal screening of the urine regarding: albumin and glucose
  • Malignant disease.
  • Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
  • Alcohol abuse.
  • Smoking.
  • Drug use or abuse.
  • Known intolerance or allergy to eprosartan or sodium nitroprusside.
  • Blood donation within 1 month of the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Location

MeSH Terms

Interventions

eprosartan

Study Officials

  • Erling B Pedersen, MD, professor

    Department of Medical Research, Holstebro Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2006

First Posted

December 12, 2006

Study Start

November 1, 2006

Last Updated

September 14, 2007

Record last verified: 2007-09

Locations

DK(1)