Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects

This study has been completed.

Sponsored by:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00344955

Purpose

We wanted to test the acute effect of HMG-CoA reductase inhibition (atorvastatin) on renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.

Condition	Intervention	Phase
Healthy	Drug: HMG-CoA reductase inhibition (atorvastatin)	Phase IV

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects

Further study details as provided by Holstebro Hospital:

Primary Outcome Measures:

GFR
RPF
FEna
FELi
CLna
CLli

Estimated Enrollment:	20
Study Start Date:	January 2003
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Both men and women
Age: Between 20-50
BMI<30

Exclusion Criteria:

Clinical signs or history of disease of heart, lungs, kidneys or endocrine organs.
Abnormal lab. tests( haemoglobin, pl. sodium, pl. potassium, pl.creatinine, pl.bilirubin, pl.ALAT, pl. cholesterol, blood glucose)
Albuminuria or glucosuria
Cancer
Art. hypertension
Alcohol abuse
Medical treatment, except oral contraceptives
Pregnancy or breast feeding
Blood donation less than 1 month before study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344955

Locations

Denmark
Medical Research
Holstebro, Denmark, 7500

Sponsors and Collaborators

Holstebro Hospital

Investigators

Study Chair:

Erling B. Pedersen, Professor

Holstebro Sygehus

More Information

Study ID Numbers:	MED.RES.HOS.2004.01.LP
Study First Received:	June 24, 2006
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00344955
Health Authority:	Denmark: Ethics Committee

Keywords provided by Holstebro Hospital:

HMG-COA reductase inhibition
GFR
RPF
FE
CL

Study placed in the following topic categories:

Healthy
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009