Pulmonary Arterial HypertensionPhase 2NCT01094067
Tezosentan in Patients With Pulmonary Arterial Hypertension
A Phase 2 study testing ACT-050089 in people with Pulmonary Arterial Hypertension, run by Idorsia Pharmaceuticals Ltd. at 5 sites in 3 countries.
Trial summary
Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- ACT-050089
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Sep 2010to 1 Sep 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of any study-mandated procedure
- Male and female patients 18 years of age or older
- Patients with PAH according to one of the following subgroups of the Dana Point Classification Group 1:
- Idiopathic, or
- Heritable, or
- Associated with connective tissue disease
Show all 12Show fewer
- Documented hemodynamic diagnosis of PAH by right heart catheterization (not part of study mandated procedures):
- Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
- Resting mean pulmonary vascular resistance (PVR) ≥ 240 dyn•s•cm 5 and
- Pulmonary capillary wedge pressure ≤ 15 mmHg
- Modified NYHA functional class II-III
- Patients on treatment with ERAs, PDE-5 inhibitors or a combination of both, if used for at least 3 months prior to Visit 1 and dosing kept stable for at least 28 days prior to Visit 1.
Who cannot join
- Patients with PAH in Dana Point Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion No. 3
- Patients with sitting SBP < 100 mmHg
- Patients with sitting DBP < 60 mmHg
- Patients with body weight < 50 kg (110 lbs)
- Patients with clinically significantly elevated liver enzymes (AST, ALT and/or alkaline phosphatase > 3 times upper limit)
- Patients with clinically significant chronic renal insufficiency (serum creatinine >2.5mg/dL / 221 µmol/L)
Show all 14Show fewer
- Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
- Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost and beraprost) within 28 days of Visit 1
- Patients who have received any investigational drugs within 28 days of Visit 1
- Patients who have received cyclosporine A (CsA) or tacrolimus within 28 days of Visit 1
- Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
- Life expectancy less than 12 months
- Females who are lactating or pregnant (positive pre-treatment pregnancy tests) (serum test at Screening and urine test on Visit 1 and 2) or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after last administration of study drug
- Known hypersensitivity to any of the excipients of the drug formulation.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Japan3 sites
Osaka University Hospital
Osaka, 565-0871
National Cardiovascular Center
Osaka, 565-8865
Keio University Hospital
Shinjuku-Ku, 160-8582
About this study
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.
Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- ACT-050089, Placebo
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-050089Drug
5 mg/h intravenously, Tezosentan
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Placebo at visit 1, tezosentan at visit 2 Receives: Drug: ACT-050089; Other: Placebo |
| 2 | Experimental | Tezosentan at visit 1, placebo at visit 2 Receives: Drug: ACT-050089; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg
Measured: 30 days
Secondary outcomes (1)
Absolute change in heart rate from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in bpm
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study start1 Sep 2010
- Primary completion1 Dec 2010
- Study completion1 Sep 2011
Why it stopped: Due to slow recruitment, the study was prematurely discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094067
- Sponsor's protocol ID
- AC-051-207
- Status last verified
- Jul 2018
- First submitted
- 25 Mar 2010
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.
- ClinicalTrials.gov ID
- NCT01094067
- Acronym / sponsor ID
- AC-051-207
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow recruitment, the study was prematurely discontinued.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2010
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 1 Sep 2011 (actual)
- First posted
- 26 Mar 2010 (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.
Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ACT-050089, Other: PlaceboPlacebo at visit 1, tezosentan at visit 2 |
| 2 | Experimental | Drug: ACT-050089, Other: PlaceboTezosentan at visit 1, placebo at visit 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent prior to initiation of any study-mandated procedure
- Male and female patients 18 years of age or older
- Patients with PAH according to one of the following subgroups of the Dana Point Classification Group 1:
- Documented hemodynamic diagnosis of PAH by right heart catheterization (not part of study mandated procedures):
- Modified NYHA functional class II-III
Key exclusion criteria (14 listed)
- Patients with PAH in Dana Point Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion No. 3
- Patients with sitting SBP < 100 mmHg
- Patients with sitting DBP < 60 mmHg
- Patients with body weight < 50 kg (110 lbs)
- Patients with clinically significantly elevated liver enzymes (AST, ALT and/or alkaline phosphatase > 3 times upper limit)
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 |
|---|---|---|
| ACT-0500895 mg/h intravenously, Tezosentan | Drug | 1, 2 |
| PlaceboMatching placebo | Other | 1, 2 |
Primary outcome
Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg
Time frame: 30 days
1 secondary outcome
Absolute change in heart rate from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in bpm
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Due to slow recruitment, the study was prematurely discontinued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT-050089 in people with Pulmonary Arterial Hypertension, run by Idorsia Pharmaceuticals Ltd. at 5 sites in 3 countries.
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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan, United States, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: Due to slow recruitment, the study was prematurely discontinued.). Results are not available in the source record.
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?
Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg (time frame: 30 days). 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 9 Jul 2018.