Short Term Effects of HMG-CoA Reductase Inhibition (Atorv... | NCT00345202 | Trialant

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Short Term Effects of HMG-CoA Reductase Inhibition (Atorv... | NCT00345202 | Trialant

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

NCT00345202

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

May 15, 2008Estimated

Enrollment

20

Phase

Phase 4

Conditions

Healthy

Interventions

HMG-CoA reductase inhibition (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

NCT00345202

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

MED.RES.HOS.2004.02.LP

Secondary IDs

Not provided

Brief Title

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

Official Title

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

Acronym

Not provided

Organization

Regional Hospital HolstebroOTHER

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

No

Start Date

Sep 2004

Primary Completion Date

Feb 2005Actual

Completion Date

Feb 2005Actual

First Submitted Date

Jun 24, 2006

First Submission Date that Met QC Criteria

Jun 26, 2006

First Posted Date

Jun 27, 2006Estimated

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

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Regional Hospital HolstebroOTHER

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

Healthy

Keywords

HMG-COA reductase inhibition
GFR
RPF
FE
CL

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

20

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HMG-CoA reductase inhibition (atorvastatin)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GFR
RPF
FEna
FELi
CLna
CLli

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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	Holstebro Sygehus	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical research unit, Department of medicin, Holstebro Sygehus		Holstebro	Ringkøbing Countie	7500	Denmark

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

Randomized

Intervention Model

Crossover Assignment

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

Not provided

ID	Term
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided