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NCT00311974 Clinical Trial

The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals

Healthy Clinical Trial

Official title:
The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311974
Other study ID # MED.RES.HOS.2006.01.HV
Secondary ID 99127500
Status Completed
Phase Phase 4
First received April 5, 2006
Last updated February 17, 2010
Start date April 2006
Est. completion date November 2007

Study information
Verified date February 2010
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

1. Men

2. Ages 18 to 40 years.

3. Body mass index less than or equal to 30 kg/m2

Exclusion Criteria:

1. History or clinical signs of heart, lung, kidney, or endocrine organ disease.

2. 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.

3. Abnormal screening of the urine regarding: albumin and glucose

4. Malignant disease.

5. Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.

6. Alcohol abuse.

7. Smoking.

8. Drug use or abuse.

9. Known intolerance or allergy to dihydralazine

10. Blood donation within 1 month of the start of the study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Dihydralazine

Locations
Country Name City State
Denmark Department of Medical Research, Holstebro Hospital Holstebro

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fractional sodium excretion
Primary Heart rate
Primary Blood pressure
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