HealthyPhase 4NCT00345202
Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects
A Phase 4 study testing HMG-CoA reductase inhibition (atorvastatin) in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HMG-CoA reductase inhibition (atorvastatin)
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2004to Feb 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both men and women
- Age: Between 20-50
- BMI<30
Who cannot join
- 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
Show all 9Show fewer
- Med. treatment, except oral contraceptives
- Pregnancy or breast feeding
- Blood donation less than 1 month before study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical research unit, Department of medicin, Holstebro Sygehus
Holstebro, Ringkøbing Countie, 7500
About this study
Official title: Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects.
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.
- Conditions
- Healthy
- Being tested
- HMG-CoA reductase inhibition (atorvastatin)
- Keywords
- HMG-COA reductase inhibition, GFR, RPF, FE, CL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMG-CoA reductase inhibition (atorvastatin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR
RPF
FEna
FELi
CLna
CLli
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startSep 2004
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B. Pedersen, Professor, Study chair, Holstebro Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345202
- Sponsor's protocol ID
- MED.RES.HOS.2004.02.LP
- Status last verified
- May 2008
- First submitted
- 24 Jun 2006
- Last updated
- 15 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00345202
- Acronym / sponsor ID
- MED.RES.HOS.2004.02.LP
- Conditions
- Healthy
- Keywords
- HMG-COA reductase inhibition, GFR, RPF, FE, CL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both men and women
- Age: Between 20-50
- BMI<30
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMG-CoA reductase inhibition (atorvastatin) | Drug | – |
Primary outcome
GFR
RPF
FEna
FELi
CLna
CLli
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B. Pedersen, Professor study chair
Holstebro Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HMG-CoA reductase inhibition (atorvastatin) in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2008.