NCT00345202

Brief Summary

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.

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 Sep 2004

Shorter than P25 for phase_4 healthy

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

September 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.4 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

5 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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical research unit, Department of medicin, Holstebro Sygehus

Holstebro, Ringkøbing Countie, 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

September 1, 2004

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

DK(1)