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

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:

Drug Information available for: Atorvastatin calcium

U.S. FDA Resources

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:

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:

Age 20-50 yr
BMI<30
Females had to use oral contraceptive treatment or IUD.

Exclusion Criteria:

Clinical signs or history of disease of the heart, lungs, kidneys, liver, brain or endocrine organs
Abnormal laboratory blood tests (hemoglobin, sodium, potassium, albumin, creatinine, blood glucose, bilirubin, alanin amino transferase, alkalic phosphatase)
Albuminuria or glucosuria
cancer
arterial hypertension
alcohol abuse
medical treatment, except contraceptives
pregnancy or breast feeding
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 May 16, 2013