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

February 17, 2010 updated by: Regional Hospital Holstebro

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

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.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Drug: Dihydralazine

Study Type

Interventional

Enrollment

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Blood pressure
Fractional sodium excretion
Heart rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 7, 2006

Study Record Updates

Last Update Posted (Estimate)

February 18, 2010

Last Update Submitted That Met QC Criteria

February 17, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MED.RES.HOS.2006.01.HV
99127500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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Clinical Trials on Dihydralazine

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