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

This study is ongoing, but not recruiting participants.

First Received: April 5, 2006 Last Updated: September 13, 2007 History of Changes

Sponsored by:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00311974

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Dihydralazine	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals

Resource links provided by NLM:

Drug Information available for: Dihydralazine Dihydralazine sulfate

U.S. FDA Resources

Further study details as provided by Holstebro Hospital:

Primary Outcome Measures:

Fractional sodium excretion
Heart rate
Blood pressure

Estimated Enrollment:	16
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Men
Ages 18 to 40 years.
Body mass index less than or equal to 30 kg/m2

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311974

Locations

Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500

Sponsors and Collaborators

Holstebro Hospital

Investigators

Study Chair:	Erling B Pedersen, Professor	Department of Medical Research, Holstebro Hospital, Denmark
Principal Investigator:	Henrik Vase, MD	Department of Medical Research, Holstebro Hospital, Denmark

More Information

No publications provided

Study ID Numbers:	MED.RES.HOS.2006.01.HV, 99127500
Study First Received:	April 5, 2006
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00311974 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Holstebro Hospital:

Dihydralazine
Sympathetic activation
Fractional sodium excretion

Study placed in the following topic categories:

Dihydralazine
Cardiovascular Agents
Healthy
Antihypertensive Agents
Hormones

Additional relevant MeSH terms:

Therapeutic Uses
Dihydralazine
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009