Pulmonary Arterial HypertensionPhase 2NCT01077297
Tezosentan in Pulmonary Arterial Hypertension
A Phase 2 study testing Tezosentan in people with Pulmonary Arterial Hypertension, run by Idorsia Pharmaceuticals Ltd. at 5 sites in 3 countries.
Trial summary
Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5… 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?
- Tezosentan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2010to 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
- Male and female patients 18 years of age or older
- Patients with PAH according to one of the following subgroups of the Venice Classification Group 1:
- Idiopathic (iPAH), or
- Familial/heritable (FPAH), or
- Associated (APAH) with collagen vascular disease
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- Modified NYHA functional class II-III
- Documented hemodynamic diagnosis of PAH by right heart catheterization at Baseline:
- Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
- Resting mean PVR ≥ 240 dyn•s•cm-5 and
- Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
Who cannot join
- Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
- Hypotensive patients (systemic systolic blood pressure < 100 mmHg)
- Patients with body weight < 50 kg (110 lbs)
- Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
- Patients with clinically significant chronic renal insufficiency (serum creatinine > 2.5mg/dL / 221µmol/L)
- Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (PDE-5) inhibitor within 28 days of Baseline
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- Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline
- Patients who have received any investigational drugs within 28 days of Baseline
- Patients who have received cyclosporine A or tacrolimus within 28 days of Baseline
- 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 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 study drug intake
- Known hypersensitivity to any of the excipients of the drug formulation
- Patients with positive response to vasoreactivity test
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Washington University School of Medicine
St Louis, Missouri, 63110
Switzerland2 sites
University Hospital of Basel, Clinic of Pneumology
Basel, CH - 4031
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, CH-1011
About this study
Official title: Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Tezosentan
- 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.
TezosentanDrug
single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Tezosentan | Experimental | Not described Receives: Drug: Tezosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.
Measured: 30 minutes
Secondary outcomes (6)
Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes
Measured: 30 minutes
Change in mPAP from Baseline to 30 min
Measured: 30 minutes
Change in total pulmonary resistance (TPR) from Baseline to 30 min
Measured: 30 minutes
Change in PCWP from Baseline to 30 min
Measured: 30 minutes
Change in cardiac output (CO) from Baseline to 30 min
Measured: 30 minutes
Change in cardiac index (CI) from Baseline to 30 min
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionSep 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabet Lindberg, MD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077297
- Sponsor's protocol ID
- AC-051-206
- Status last verified
- Jul 2018
- First submitted
- 25 Feb 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
- Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
- ClinicalTrials.gov ID
- NCT01077297
- Acronym / sponsor ID
- AC-051-206
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow recruitment, the study was prematurely discontinued
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 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, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tezosentan | Experimental | Drug: Tezosentan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent
- Male and female patients 18 years of age or older
- Patients with PAH according to one of the following subgroups of the Venice Classification Group 1:
- Modified NYHA functional class II-III
- Documented hemodynamic diagnosis of PAH by right heart catheterization at Baseline:
Key exclusion criteria (14 listed)
- Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
- Hypotensive patients (systemic systolic blood pressure < 100 mmHg)
- Patients with body weight < 50 kg (110 lbs)
- Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
- Patients with clinically significant chronic renal insufficiency (serum creatinine > 2.5mg/dL / 221µmol/L)
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 |
|---|---|---|
| Tezosentansingle infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg | Drug | Tezosentan |
Primary outcome
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.
Time frame: 30 minutes
6 secondary outcomes
Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes
Time frame: 30 minutes
Change in mPAP from Baseline to 30 min
Time frame: 30 minutes
Change in total pulmonary resistance (TPR) from Baseline to 30 min
Time frame: 30 minutes
Change in PCWP from Baseline to 30 min
Time frame: 30 minutes
Change in cardiac output (CO) from Baseline to 30 min
Time frame: 30 minutes
Change in cardiac index (CI) from Baseline to 30 min
Time frame: 30 minutes
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.
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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.
Elisabet Lindberg, MD study director
Actelion
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 Tezosentan 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 11 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 United States, Switzerland, 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?
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value. (time frame: 30 minutes). 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.