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NCT00678184 Clinical Trial

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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00678184
Other study ID # MED.RES.HOS.2006.03.LP
Secondary ID
Status Completed
Phase Phase 4
First received May 13, 2008
Last updated May 14, 2008
Start date January 2007
Est. completion date October 2007

Study information
Verified date May 2008
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
80 mg atorvastatin on two following days each

Locations
Country Name City State
Denmark Department of Medical Research, Holstebro Hospital Holstebro
Denmark Medical Research Holstebro

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glomerular filtration rate, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, free water clearance 6 months
Secondary AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR. 6 months
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