HypertensionPhase 2/3NCT00152633
Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
A Phase 2/3 study testing Losartan and Metoprolol in people with Hypertension, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Essential hypertension is commonly associated with impaired endothelial function. The retinal vasculature is morphologically and functionally related to the cerebral vessels because of the common origin from the internal carotid artery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Losartan and Metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Jan 2006
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18-65 years with essential hypertension
Who cannot join
- Secondary forms of hypertension
- Advanced damage of vital organs (grade III and IV retinopathy)
- History of serious hypersensitivity reaction to AT1-receptor blockers
- Actual or anamnestic alcohol- or drug abuse.
- Smokers or ex-smokers < 1 year.
- Patients with Diabetes mellitus (oral medication or insulin).
Show all 16Show fewer
- Patients with arterial fibrillation or AV-Block (II° or more).
- Patients with anamnestic myocardial infarction.
- Patients with instable angina pectoris including EcG-aberrations or cardiac insufficiency NYHA III or IV.
- History of malignancy (unless a documented disease-free period exceeding 10 years is present) with teh exception of basal cell carcinoma of the skin
- History of allograft transplantation
- Therapy with not approved concomitant medication, or participation in a clinical study within 4 weeks preceding treatment start.
- Disease which interfere with the pharmacodynamics and pharmacokinetics of the study drug.
- Liver-or kidney disease with SGOT, GPT, g-GT, AP, bilirubin and creatinin or above 200% of standard.
- Patients, who are not sufficiently compliant, or patients, who are not capable or willing to appear for controlling vistas.
- Presumed risk of transmission of HIV or hepatitis via blood from the participant
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRC, Med. Klinik 4, University of Erlangen-Nürnberg
Erlangen, 91054
About this study
Essential hypertension is commonly associated with impaired endothelial function. The retinal vasculature is morphologically and functionally related to the cerebral vessels because of the common origin from the internal carotid artery. A recent study in hypertensive patients demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive patients and that it can be restored by treatment with an AT1-receptor antagonist. It is not clear whether this effect is due to blood pressure lowering or whether this is a blood pressure independent effect. The present randomized, double blind study with a cross over design addresses this issue by comparing the effects of losartan and metoprolol on retinal endothelial function in patients with essential hypertension.
- Conditions
- Hypertension
- Being tested
- Losartan, Metoprolol
- Keywords
- endothelium, hypertension, retina, AT1
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Active comparator | Treatment with Losartan. Receives: Drug: Losartan |
| Betablocker | Active comparator | Treatment with Metoprolol. Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal endothelial function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2006
- Study completionJan 2006
Why it stopped: No patient could be recruited.
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.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
- Investigators
- Roland E Schmieder, MD, Principal investigator, CRC, Med. Klinik 4, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152633
- Sponsor's protocol ID
- Retina-Losartan
- Status last verified
- Jul 2012
- First submitted
- 8 Sep 2005
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00152633
- Acronym / sponsor ID
- Retina-Losartan
- Conditions
- Hypertension
- Keywords
- endothelium, hypertension, retina, AT1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient could be recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 9 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.
Essential hypertension is commonly associated with impaired endothelial function. The retinal vasculature is morphologically and functionally related to the cerebral vessels because of the common origin from the internal carotid artery. A recent study in hypertensive patients demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive patients and that it can be restored by treatment with an AT1-receptor antagonist. It is not clear whether this effect is due to blood pressure lowering or whether this is a blood pressure independent effect. The present randomized, double blind study with a cross over design addresses this issue by comparing the effects of losartan and metoprolol on retinal endothelial function in patients with essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Active comparator | Drug: LosartanTreatment with Losartan. |
| Betablocker | Active comparator | Drug: MetoprololTreatment with Metoprolol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients aged 18-65 years with essential hypertension
Key exclusion criteria (16 listed)
- Secondary forms of hypertension
- Advanced damage of vital organs (grade III and IV retinopathy)
- History of serious hypersensitivity reaction to AT1-receptor blockers
- Actual or anamnestic alcohol- or drug abuse.
- Smokers or ex-smokers < 1 year.
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 |
|---|---|---|
| Losartan | Drug | Losartan |
| Metoprolol | Drug | Betablocker |
| LosartanTreatment with Losartan | Drug | Losartan |
Primary outcome
Change in retinal endothelial function
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
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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.
Roland E Schmieder, MD principal investigator
CRC, Med. Klinik 4, University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Losartan and Metoprolol in people with Hypertension, run by University of Erlangen-Nürnberg Medical School 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 1 inclusion and 16 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: withdrawn, as of the sponsor's last update on 6 Jul 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in retinal endothelial function. 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 6 Jul 2012.