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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00678184 |
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Date of registration:
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13/05/2008 |
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Primary sponsor: |
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Public title:
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The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake
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Scientific title:
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The Effect of Acute HMG-CoA-Reductase Inhibition (Atorvastatin) on Renal Sodium Excretion, Renal Hemodynamics, Tubular Function and Vasoactive Hormones in Healthy Subjects During Normal and High Sodium Intake |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00678184 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Erling B. Pedersen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of medical reaserch, Holstebro Hospital, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 20-50 yr
2. BMI<30
3. Females had to use oral contraceptive treatment or IUD.
Exclusion Criteria:
1. Clinical signs or history of disease of the heart, lungs, kidneys, liver, brain or
endocrine organs
2. Abnormal laboratory blood tests (hemoglobin, sodium, potassium, albumin, creatinine,
blood glucose, bilirubin, alanin amino transferase, alkalic phosphatase)
3. Albuminuria or glucosuria
4. cancer
5. arterial hypertension
6. alcohol abuse
7. medical treatment, except contraceptives
8. pregnancy or breast feeding
9. blood donation one month before the study.
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Subjects
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Intervention(s)
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Drug: Atorvastatin
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Primary Outcome(s)
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Glomerular filtration rate, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, free water clearance
[Time Frame: 6 months]
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Secondary Outcome(s)
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AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR.
[Time Frame: 6 months]
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Secondary ID(s)
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MED.RES.HOS.2006.03.LP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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