HypertensionNCT00561327
PPARgamma Activation by Losartan in Hypertensive Patients: The Importance of Losartan-Metabolites
An observational study of Hypertension, run by German Heart Institute at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether losartan metabolites are effective in inducing PPARγ target genes in monocytes in losartan-treated patients. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- losartan
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Sep 2007to not given
- Phase
- Observational
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 19-80
- Sex: male or female
- Prior diagnosis of treated hypertension
- Treatment with losartan 100mg/daily during at least the past 2 months (n=20/ case);
- or: no prior angiotensin receptor 1-blocker treatment during the last 2 months (n=10/ control).
Who cannot join
- Non-steroidal anti-inflammatory drugs (exception: Acetyl salicylic acid) for the past 21 days (due to structural homologies to glitazones, and activating effects on PPARγ)
- Therapy with glitazones for the past 21 days.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Heart Institute
Berlin, State of Berlin, 13353
Eckart Fleck, Prof, +49-30-4593 2400, fleck@dhzb.de
Philipp Stawowy, Dr, +49-30-45932473, stawowy@dhzb.de
About this study
The purpose of this study is to determine whether losartan metabolites are effective in inducing PPARγ target genes in monocytes in losartan-treated patients.
Read the detailed description
The losartan metabolite EXP3179 potently induces the activity of the peroxisome proliferator-activated receptor γ (PPAR-γ) as a partial agonist in vitro. PPAR-γ is a nuclear hormone receptor and functions as a regulator of lipid- and glucose metabolism. PPAR-γ ligands improve insulin sensitivity and glucose tolerance, and reduce cardiovascular morbidity and mortality in diabetic patients.
Angiotensin II receptor 1-blocking and PPAR-γ-activating properties of losartan metabolites in patients would markedly improve the pharmacological profile of losartan by combining anti-hypertensive and highly beneficial metabolic actions. We developed the following hypothesis:
- Hypertensive patients chronically treated with losartan exhibit sufficient plasma levels of EXP3179 to activate PPARγ.
- PPARγ target genes are induced in monocytes from losartan-treated patients.
- Conditions
- Hypertension
- Being tested
- losartan
- Keywords
- hypertension, angiotensin receptor blockers, peroxisome proliferator activated receptor gamma
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
losartanDrug
Daily treated with losartan 100mg for at least the past 2 months (retrospective, no new drug treatment/ intervention)
| Study group | Role | What they receive |
|---|---|---|
| A | Patients chronically treated with drug losartan Receives: Drug: losartan | |
| B | Patients not chronically treated with losartan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Merck Sharp & Dohme LLC
- Investigators
- Eckart Fleck, Prof, Principal investigator, German Heart InstituteUlrich Kintscher, Prof, Principal investigator, Institute of Pharmacology Charite University Medicine Berlin Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561327
- Sponsor's protocol ID
- P2132V1
- Status last verified
- Jul 2007
- First submitted
- 16 Nov 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPARgamma Activation by Losartan in Hypertensive Patients: The Importance of Losartan-Metabolites
- ClinicalTrials.gov ID
- NCT00561327
- Acronym / sponsor ID
- P2132V1
- Conditions
- Hypertension
- Keywords
- hypertension, angiotensin receptor blockers, peroxisome proliferator activated receptor gamma
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Merck Sharp & Dohme LLC
- Study start
- Sep 2007
- First posted
- 20 Nov 2007 (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.
The purpose of this study is to determine whether losartan metabolites are effective in inducing PPARγ target genes in monocytes in losartan-treated patients.
Detailed description
The losartan metabolite EXP3179 potently induces the activity of the peroxisome proliferator-activated receptor γ (PPAR-γ) as a partial agonist in vitro. PPAR-γ is a nuclear hormone receptor and functions as a regulator of lipid- and glucose metabolism. PPAR-γ ligands improve insulin sensitivity and glucose tolerance, and reduce cardiovascular morbidity and mortality in diabetic patients.
Angiotensin II receptor 1-blocking and PPAR-γ-activating properties of losartan metabolites in patients would markedly improve the pharmacological profile of losartan by combining anti-hypertensive and highly beneficial metabolic actions. We developed the following hypothesis:
- Hypertensive patients chronically treated with losartan exhibit sufficient plasma levels of EXP3179 to activate PPARγ.
- PPARγ target genes are induced in monocytes from losartan-treated patients.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: losartanPatients chronically treated with drug losartan |
| B | – | –Patients not chronically treated with losartan |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 19-80
- Sex: male or female
- Prior diagnosis of treated hypertension
- Treatment with losartan 100mg/daily during at least the past 2 months (n=20/ case);
- or: no prior angiotensin receptor 1-blocker treatment during the last 2 months (n=10/ control).
Key exclusion criteria (2 listed)
- Non-steroidal anti-inflammatory drugs (exception: Acetyl salicylic acid) for the past 21 days (due to structural homologies to glitazones, and activating effects on PPARγ)
- Therapy with glitazones for the past 21 days.
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 |
|---|---|---|
| losartanDaily treated with losartan 100mg for at least the past 2 months (retrospective, no new drug treatment/ intervention) | Drug | A |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2007.
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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.
Eckart Fleck, Prof principal investigator
German Heart Institute
Ulrich Kintscher, Prof principal investigator
Institute of Pharmacology Charite University Medicine Berlin Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by German Heart Institute 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Nov 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eckart Fleck, Prof (+49-30-4593-2400, fleck@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 20 Nov 2007.