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

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00345202
First received: June 24, 2006
Last updated: May 14, 2008
Last verified: May 2008
History of Changes
  Purpose

We wanted to test the shortterm effects 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • GFR
  • RPF
  • FEna
  • FELi
  • CLna
  • CLli

Estimated Enrollment: 20
Study Start Date: September 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (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:

  • Cl. 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
  • Med. 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: NCT00345202

Locations
Denmark
Medical research unit, Department of medicin, Holstebro Sygehus
Holstebro, Ringkøbing countie, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B. Pedersen, Professor Holstebro Sygehus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00345202     History of Changes
Other Study ID Numbers: MED.RES.HOS.2004.02.LP
Study First Received: June 24, 2006
Last Updated: May 14, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by Regional Hospital Holstebro:
HMG-COA reductase inhibition
GFR
RPF
FE
CL

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