Pulmonary HypertensionPhase 3NCT00519870
Losartan Therapy in Pulmonary Hypertension
A Phase 3 study testing nifedipine, losartan and losartan in people with Pulmonary Hypertension, run by Baskent University.
Trial summary
In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- nifedipine, losartan and losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 2005
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pulmonary hypertension diagnosed by Doppler echocardiographic examination (a mean pulmonary artery pressure of > 26mmHg)
Who cannot join
- acute infectious or inflammatory disease,
- exacerbation of chronic obstructive pulmonary disease,
- malignancy,
- acute coronary syndrome in the last 4 weeks,
- uncontrolled arrhythmia and hypertension,
- decompensated heart failure,
Show all 10Show fewer
- acute pulmonary emboli,
- thrombus in a lower extremity,
- oxygen saturation below 85% at rest,
- failure to cooperate with CPET
About this study
Official title: Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension
In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction. These beneficial effects, render those agents appropriate for use in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise test, and endothelin-1 levels.Losartan is as effective as nifedipine for reducing Doppler echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However the short-term use of losartan or nifedipine had no statistically significant effect on endothelin-1 levels in patients with PHT.
- Conditions
- Pulmonary Hypertension
- Being tested
- nifedipine, losartan, losartan
- Keywords
- Pulmonary hypertension, Angiotensin receptor blocker, Calcium channel blocker
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nifedipine, losartanDrug
Also called nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany), losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA)
I: nifedipine 30 mg/d II: losartan 50 mg/d
losartanDrug
Also called losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d
II: losartan
Nifedipine, losartanDrug
I: nifedipine II: losartan
| Study group | Role | What they receive |
|---|---|---|
| I, II | Active comparator | I: nifedipine II: losartan Receives: Drug: nifedipine, losartan; Drug: losartan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJan 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Serife Savas Bozbas, MD, Principal investigator, Baskent University Faculty of Medicine, Department of Pulmonary DiseaseFusun Oner Eyuboglu, MD, Study chair, Baskent University Faculty of Medicine, Department of Pulmonary Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519870
- Sponsor's protocol ID
- KA04/127
- Status last verified
- Aug 2007
- First submitted
- 22 Aug 2007
- Last updated
- 23 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00519870
- Acronym / sponsor ID
- KA04/127
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Angiotensin receptor blocker, Calcium channel blocker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jul 2005
- First posted
- 23 Aug 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.
In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction. These beneficial effects, render those agents appropriate for use in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise test, and endothelin-1 levels.Losartan is as effective as nifedipine for reducing Doppler echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However the short-term use of losartan or nifedipine had no statistically significant effect on endothelin-1 levels in patients with PHT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I, II | Active comparator | Drug: nifedipine, losartan, Drug: losartanI: nifedipine II: losartan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pulmonary hypertension diagnosed by Doppler echocardiographic examination (a mean pulmonary artery pressure of > 26mmHg)
Key exclusion criteria (10 listed)
- acute infectious or inflammatory disease,
- exacerbation of chronic obstructive pulmonary disease,
- malignancy,
- acute coronary syndrome in the last 4 weeks,
- uncontrolled arrhythmia and 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 |
|---|---|---|
| nifedipine, losartanAlso: nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany), losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA)I: nifedipine 30 mg/d II: losartan 50 mg/d | Drug | I, II |
| losartanAlso: losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/dII: losartan | Drug | I, II |
| Nifedipine, losartanI: nifedipine II: losartan | Drug | I, II |
Primary outcome
Not reported in the source record.
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 23 Aug 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.
Serife Savas Bozbas, MD principal investigator
Baskent University Faculty of Medicine, Department of Pulmonary Disease
Fusun Oner Eyuboglu, MD study chair
Baskent University Faculty of Medicine, Department of Pulmonary Disease
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nifedipine, losartan and losartan in people with Pulmonary Hypertension, run by Baskent University.
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 10 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 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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 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 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.
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 23 Aug 2007.