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
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR. [ Time Frame: 6 months ]

Enrollment: 23
Study Start Date: January 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Atorvastatin
    80 mg atorvastatin on two following days each
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678184

Locations
Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Medical Research
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Erling B. Pedersen, Professor Dept. of medical reaserch, Holstebro Hospital, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00678184     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.03.LP
Study First Received: May 13, 2008
Last Updated: May 14, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Regional Hospital Holstebro:
Atorvastatin
healthy
sodium excretion
hemodynamics
tubular function

Additional relevant MeSH terms:
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014