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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311974
First Posted: April 7, 2006
Last Update Posted: February 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Regional Hospital Holstebro
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Fractional sodium excretion
  • Heart rate
  • Blood pressure

Estimated Enrollment: 16
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311974


Locations
Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
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
  More Information

ClinicalTrials.gov Identifier: NCT00311974     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.01.HV
99127500
First Submitted: April 5, 2006
First Posted: April 7, 2006
Last Update Posted: February 18, 2010
Last Verified: February 2010

Keywords provided by Regional Hospital Holstebro:
Dihydralazine
Sympathetic activation
Fractional sodium excretion

Additional relevant MeSH terms:
Hormones
Dihydralazine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents