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

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ClinicalTrials.gov Identifier: NCT00311974
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Regional Hospital Holstebro

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dihydralazine Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals
Study Start Date : April 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources




Primary Outcome Measures :
  1. Fractional sodium excretion
  2. Heart rate
  3. Blood pressure


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.

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

ClinicalTrials.gov Identifier: NCT00311974     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.01.HV
99127500
First Posted: April 7, 2006    Key Record Dates
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