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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01112306
Registration number
NCT01112306
Ethics application status
Date submitted
8/04/2010
Date registered
28/04/2010
Date last updated
8/12/2023
Titles & IDs
Public title
ACT-293987 in Pulmonary Arterial Hypertension
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Scientific title
Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension
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Secondary ID [1]
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2009-014992-31
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Secondary ID [2]
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AC-065A303
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
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0
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
0
0
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0
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Other human genetics and inherited disorders
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Cardiovascular
0
0
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ACT-293987
Experimental: 1 - ACT-293987, twice daily
Treatment: Drugs: ACT-293987
Tablets, twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation
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Assessment method [1]
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An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
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Timepoint [1]
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Up to 3 days after study drug discontinuation (Up to 10.5 years)
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Primary outcome [2]
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Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation
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Assessment method [2]
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.
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Timepoint [2]
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Up to 3 days after study drug discontinuation (Up to 10.5 years)
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Primary outcome [3]
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Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention
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Assessment method [3]
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An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
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Timepoint [3]
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Up to 10.5 years
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Secondary outcome [1]
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Percentage of Alive Participants
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Assessment method [1]
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Percentage of alive participants were analyzed using Kaplan-Meier (KM) estimates.
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Timepoint [1]
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Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
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Eligibility
Key inclusion criteria
- Patients who participated to the double-blind study AC-065A302 and either had a
morbidity event or had completed the study as scheduled per protocol.
- Signed informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin
analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in
AC-065A302/GRIPHON.
- Severe hepatic impairment (Child-Pugh C).
- Females who are pregnant or who plan to become pregnant during the study, or are
breastfeeding.
- Any known factor or disease that might interfere with treatment compliance, study
conduct or interpretation of the results, such as drug or alcohol dependence, or
psychiatric disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/08/2021
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Sample size
Target
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Accrual to date
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Final
709
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Bedford Park
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- Chermside
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- Concord
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- Darlinghurst
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- Fitzroy
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- Hobart
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- Murdoch
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- New Lambton
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- Parkville
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- Adelaide
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- Bedford Park
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- Chermside
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- Concord
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- Murdoch
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- Parkville
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Actelion
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Summary
Brief summary
Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the
safety and tolerability of ACT-293987 in patients with PAH who participated in the
double-blind study AC-065A302 (GRIPHON)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01112306
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Contacts
Principal investigator
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Aline Frey
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Actelion
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01112306
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