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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
2009-014992-31
Secondary ID [2] 0 0
AC-065A303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACT-293987

Experimental: 1 - ACT-293987, twice daily


Treatment: Drugs: ACT-293987
Tablets, twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation
Timepoint [1] 0 0
Up to 3 days after study drug discontinuation (Up to 10.5 years)
Primary outcome [2] 0 0
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation
Timepoint [2] 0 0
Up to 3 days after study drug discontinuation (Up to 10.5 years)
Primary outcome [3] 0 0
Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention
Timepoint [3] 0 0
Up to 10.5 years
Secondary outcome [1] 0 0
Percentage of Alive Participants
Timepoint [1] 0 0
Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2021
Sample size
Target
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bedford Park
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Concord
Recruitment hospital [5] 0 0
- Darlinghurst
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Hobart
Recruitment hospital [8] 0 0
- Murdoch
Recruitment hospital [9] 0 0
- New Lambton
Recruitment hospital [10] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Concord
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- Darlinghurst
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- Fitzroy
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- Hobart
Recruitment postcode(s) [8] 0 0
- Murdoch
Recruitment postcode(s) [9] 0 0
- New Lambton
Recruitment postcode(s) [10] 0 0
- Parkville
Recruitment outside Australia
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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North Carolina
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Oregon
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Cordoba
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Corrientes
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Graz
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aline Frey
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01112306