Healthy SubjectsNCT00154024
Comparison of Vascular Effects After Therapy With Irbesartan and Atorvastatin.
A study testing atorvastatin and irbesartan in people with Healthy Subjects, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- atorvastatin and irbesartan
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Oct 2006
- Phase
- Interventional
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- no relevant disease
- amendment: hypercholesterolaemic subjects
Who cannot join
- any relevant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Clinical Pharmacology, Medical Faculty, University of Technology
Dresden, 01307
About this study
Official title: Characterization of Local Vascular Effects of Angiotensin II and Histamine After Treatment With Irbesartan and Atorvastatin.
Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.
Read the detailed description
Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.
- Conditions
- Healthy Subjects
- Being tested
- atorvastatin, irbesartan
- Keywords
- venoconstriction, venodilation, pleiotropic effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
irbesartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular responses after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2003
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Wilhelm Kirch, MD, Study chair, Institute of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154024
- Sponsor's protocol ID
- IKPD 03-02
- Status last verified
- Jul 2006
- First submitted
- 8 Sep 2005
- Last updated
- 28 Sep 2006
- Results posted
- No
Publications
Schindler C, Guenther K, Hermann C, Ferrario CM, Schroeder C, Haufe S, Jordan J, Kirch W. Statin treatment in hypercholesterolemic men does not attenuate angiotensin II-induced venoconstriction. PLoS One. 2014 Sep 29;9(9):e103909. doi: 10.1371/journal.pone.0103909. eCollection 2014.
PubMed 25264877
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Local Vascular Effects of Angiotensin II and Histamine After Treatment With Irbesartan and Atorvastatin.
- ClinicalTrials.gov ID
- NCT00154024
- Acronym / sponsor ID
- IKPD 03-02
- Conditions
- Healthy Subjects
- Keywords
- venoconstriction, venodilation, pleiotropic effects
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Oct 2006
- First posted
- 12 Sep 2005 (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.
Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.
Detailed description
Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy subjects
- no relevant disease
- amendment: hypercholesterolaemic subjects
Key exclusion criteria (1 listed)
- any relevant disease
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 |
|---|---|---|
| atorvastatin | Drug | – |
| irbesartan | Drug | – |
Primary outcome
vascular responses after treatment.
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 28 Sep 2006.
- Derived from this study: PubMed 25264877Schindler C, Guenther K, Hermann C, Ferrario CM, Schroeder C, Haufe S, Jordan J, Kirch W. Statin treatment in hypercholesterolemic men does not attenuate angiotensin II-induced venoconstriction. PLoS One. 2014 Sep 29;9(9):e103909. doi: 10.1371/journal.pone.0103909. eCollection 2014.
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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.
Wilhelm Kirch, MD study chair
Institute of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin and irbesartan in people with Healthy Subjects, run by Technische Universität Dresden at 1 site in Germany.
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 1 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 28 Sep 2006. 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 Germany. 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.
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?
vascular responses after treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00154024, which also lists 1 linked publication.
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 28 Sep 2006.