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The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00678184
First received: May 13, 2008
Last updated: May 14, 2008
Last verified: May 2008
History of Changes

May 13, 2008
May 14, 2008
January 2007
October 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00678184 on ClinicalTrials.gov Archive Site
AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR. [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake
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

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

We wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood pressure and HR under acute treatment with atorvastatin depends on sodium intake.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Subjects
Drug: Atorvastatin
80 mg atorvastatin on two following days each
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00678184
MED.RES.HOS.2006.03.LP
Yes
Not Provided
Regional Hospital Holstebro
Not Provided
Principal Investigator: Erling B. Pedersen, Professor Dept. of medical reaserch, Holstebro Hospital, Denmark
Regional Hospital Holstebro
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP