Printed from Voxsanity (voxsanity.com.au) — NCT01106014 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.
Trial results
AI generated results summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01106014) involved 1,156 people with pulmonary arterial hypertension (a condition where blood pressure in the lungs is abnormally high). Of these, 574 were assigned to receive selexipag and 582 received a placebo (a dummy treatment with no active ingredient). The trial's main goal was to track how long it took before participants experienced a serious health setback — such as being hospitalised due to their condition worsening, needing a lung transplant, starting certain intensive treatments, or dying — for up to seven days after they finished taking the study medication.
The reported data shows the percentage of participants who had not yet experienced one of those serious events at various points in time. In the selexipag group, that figure started at 91.2% and fell to 58.2% by the final measured time point. In the placebo group, it started at 81.7% and fell to 41.7% by the same point. For a secondary measure — how far participants could walk in six minutes — the reported data shows that the selexipag group's average walking distance changed by approximately +4 metres from their starting point at week 26, while the placebo group's average changed by approximately −9 metres. For another secondary measure — the proportion of participants whose WHO functional class (a rating of how much their condition limits daily activity) did not worsen by week 26 — the reported figures were 77.8% in the selexipag group and 74.9% in the placebo group.
These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Pulmonary Hypertension Trial, Completed
NCT01106014
CompletedPhase 3🇦🇺 Australian site
Who may be able to join
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
You are between 18 and 75 years old (male or female) and have symptoms of pulmonary arterial hypertension (PAH), a condition causing high blood pressure in the lungs
Your PAH falls into one of these specific categories: no known cause (idiopathic), inherited (runs in the family), caused by a drug or toxin, or linked to a connective tissue disease, a repaired heart defect (at least 1 year after surgery), or HIV infection
You have had a confirmed diagnosis of PAH through a procedure called a right heart catheterization at some point before the study screening
In a 6-minute walking test done within 2 weeks before the study starts, you were able to walk between 50 and 450 metres
You are willing and able to sign a consent form agreeing to take part
Who may not be able to join:
Your type of pulmonary hypertension does not match the specific categories listed above
You have taken prostacyclin or similar medications within the last month, or are expected to take them during the trial
You have moderate or severe chronic obstructive lung disease (such as COPD)
You have moderate or severe restrictive lung disease (a condition limiting how much air your lungs can hold)
You have moderate or severe liver problems
You have been diagnosed with a weakened or poorly functioning left side of the heart
You have severe kidney problems
Your Body Mass Index (BMI) is below 18.5 (considered underweight)
You have taken part in another drug trial within the last month before the study starts
You have a physical condition (other than breathlessness) that would prevent you from completing study activities, especially the 6-minute walking test
You have recently completed or are planning to take part in a cardiac or pulmonary rehabilitation programme involving exercise training
You have a mental health condition, addiction, or other issue that would make it difficult to give informed consent or follow the study rules
Your doctors estimate your life expectancy is less than 12 months
You are currently breastfeeding, pregnant, or planning to become pregnant during the study
You have a known allergy to any ingredient in the study medications
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Aline Frey, Actelion
Australian sites
St. Vincent's Hospital / Heart and Lung Transplant Unit, Darlinghurst, New South Wales
Prince Charles Hospital Lung Transplant, Thoracic Department, Chermside, Queensland
Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU), Adelaide, South Australia
Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology, Bedford Park, South Australia
St Vincent's Hospital, Fitzroy, Victoria
Royal Hobart Hospital, Centre for Clinical Research, Hobart,
John Hunter Hospital Autoimmune Resource and Research Centre, New Lambton,
Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine, Parkville,
Royal Perth Hospital, Perth,
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:
Trial: NCT01106014
Sponsor: Actelion
Phase: Phase 3
Status: Completed
Condition: Pulmonary Hypertension
More information: https://clinicaltrials.gov/study/NCT01106014
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You are between 18 and 75 years old (male or female) and have symptoms of pulmonary arterial hypertension (PAH), a condition causing high blood pressure in the lungs
Your PAH falls into one of these specific categories: no known cause (idiopathic), inherited (runs in the family), caused by a drug or toxin, or linked to a connective tissue disease, a repaired heart defect (at least 1 year after surgery), or HIV infection
You have had a confirmed diagnosis of PAH through a procedure called a right heart catheterization at some point before the study screening
In a 6-minute walking test done within 2 weeks before the study starts, you were able to walk between 50 and 450 metres
You are willing and able to sign a consent form agreeing to take part
Who may not be able to join:
Your type of pulmonary hypertension does not match the specific categories listed above
You have taken prostacyclin or similar medications within the last month, or are expected to take them during the trial
You have moderate or severe chronic obstructive lung disease (such as COPD)
You have moderate or severe restrictive lung disease (a condition limiting how much air your lungs can hold)
You have moderate or severe liver problems
You have been diagnosed with a weakened or poorly functioning left side of the heart
You have severe kidney problems
Your Body Mass Index (BMI) is below 18.5 (considered underweight)
You have taken part in another drug trial within the last month before the study starts
You have a physical condition (other than breathlessness) that would prevent you from completing study activities, especially the 6-minute walking test
You have recently completed or are planning to take part in a cardiac or pulmonary rehabilitation programme involving exercise training
You have a mental health condition, addiction, or other issue that would make it difficult to give informed consent or follow the study rules
Your doctors estimate your life expectancy is less than 12 months
You are currently breastfeeding, pregnant, or planning to become pregnant during the study
You have a known allergy to any ingredient in the study medications
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Completed
Phase
Phase 3
Sponsor
Actelion
Registry
ClinicalTrials.gov
Start date
1 December 2009
Est. completion
1 April 2014
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
Belarus
🇧🇪 Belgium
🇨🇦 Canada
🇨🇱 Chile
🇨🇳 China
🇨🇴 Colombia
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇷 France
🇩🇪 Germany
🇬🇷 Greece
🇭🇺 Hungary
🇮🇳 India
🇮🇪 Ireland
🇮🇱 Israel
🇮🇹 Italy
🇲🇾 Malaysia
🇲🇽 Mexico
🇳🇱 Netherlands
🇵🇪 Peru
🇵🇱 Poland
🇷🇴 Romania
🇷🇺 Russia
🇷🇸 Serbia
🇸🇬 Singapore
🇸🇰 Slovakia
🇰🇷 South Korea
🇪🇸 Spain
🇸🇪 Sweden
🇨🇭 Switzerland
🇹🇼 Taiwan
🇹🇭 Thailand
Turkey (Türkiye)
🇺🇦 Ukraine
🇬🇧 United Kingdom
🇺🇸 United States
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.