The Effect of Atorvastatin on Renal Function in Healthy S... | NCT00678184

Studies
The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake

NCT00678184

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

May 15, 2008Estimated

Enrollment

23Actual

Phase

Phase 4

Conditions

Healthy Subjects

Interventions

Atorvastatin

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

May 13, 2008

First Submission Date that Met QC Criteria

May 14, 2008

First Posted Date

May 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2008

Last Update Posted Date

May 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

We wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood pressure and HR under acute treatment with atorvastatin depends on sodium intake.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	80 mg atorvastatin on two following days each

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR.		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B. Pedersen, Professor	Dept. of medical reaserch, Holstebro Hospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Research, Holstebro Hospital		Holstebro		7500	Denmark
Medical Research

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided