NCT00678184

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

Enrollment Period

9 months

First QC Date

May 13, 2008

Last Update Submit

May 14, 2008

Conditions

Healthy Subjects

Keywords

Atorvastatinhealthysodium excretionhemodynamicstubular function

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, free water clearance

    6 months

Secondary Outcomes (1)

  • AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR.

    6 months

Interventions

AtorvastatinDRUG

80 mg atorvastatin on two following days each

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Location

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

    Dept. of medical reaserch, Holstebro Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

January 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

DK(2)