NCT00344955

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

June 24, 2006

Last Update Submit

May 14, 2008

Conditions

Healthy

Keywords

HMG-COA reductase inhibitionGFRRPFFECL

Outcome Measures

Primary Outcomes (6)

  • GFR

  • RPF

  • FEna

  • FELi

  • CLna

  • CLli

Interventions

HMG-CoA reductase inhibition (atorvastatin)DRUG

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research

Holstebro, 7500, Denmark

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Erling B. Pedersen, Professor

    Holstebro Sygehus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2006

First Posted

June 27, 2006

Study Start

January 1, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

DK(1)