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

NCT ID: NCT00678184

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Subjects

Keywords

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Atorvastatin healthy sodium excretion hemodynamics tubular function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Atorvastatin

80 mg atorvastatin on two following days each

Intervention Type DRUG

Eligibility 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Principal Investigators

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Erling B. Pedersen, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of medical reaserch, Holstebro Hospital, Denmark

Locations

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Department of Medical Research, Holstebro Hospital

Holstebro, , Denmark

Site Status

Medical Research

Holstebro, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MED.RES.HOS.2006.03.LP

Identifier Type: -

Identifier Source: org_study_id