UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006740 |
|---|---|
| Receipt number | R000007963 |
| Scientific Title | Open-label study ACT-385781A in patients with pulmonary arterial hypertension |
| Date of disclosure of the study information | 2011/11/22 |
| Last modified on | 2012/03/27 08:25:10 |
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Basic information
Public title
Open-label study ACT-385781A in patients with pulmonary arterial hypertension
Acronym
Open-label study ACT-385781A in patients with pulmonary arterial hypertension
Scientific Title
Open-label study ACT-385781A in patients with pulmonary arterial hypertension
Scientific Title:Acronym
Open-label study ACT-385781A in patients with pulmonary arterial hypertension
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and tolerability of switching from Flolan to ACT-385781A in patients with PAH.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment-emergent adverse events (AEs) up to 24 hours post-EOT
_ Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT
_ AEs leading to premature discontinuation of study drug
_ Change from baseline to Visit7 in vital signs [heart rate (HR) and blood pressure (BP)] and body weight
_ Change from baseline to EOT in laboratory values
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch from Flolan to ACT-385781A and continue the medication of ACT-385781A by the end of study.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Male or female aged 20 years and above
2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I:
_ Idiopathic (IPAH)
_ Heritable (HPAH)
_ Associated (APAH) with Drugs and toxins
_ Associated (APAH) with Connective tissue diseases
3. Patients treated with Flolan for at least 3 months and on a stable dose for at least 30 day prior to enrollment
4. Females who are lactating or pregnant (positive pre-treatment pregnancy tests) or females who are not using a reliable method of birth control during the study and for at least one month after last administration of study drug
5. Signed informed consent prior to initiation of any study mandated procedure
Key exclusion criteria
1. Patients with respiratory and/or cardiovascular distress in need of emergency care
2. Known or suspicion of pulmonary veno-occlusive disease (PVOD)
3. Current use of IV inotropic agents
4. Current use of any prostacyclin or prostacyclin analog other than Flolan.
5. Tachycardia with heart rate > 120 beats/min at rest
6. Known hypersensitivity to the formulations ACT-385781A or any of its excipients, and Flolan or any of its excipients
7. Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
8. History of myocardial infarction
9. History of left-sided heart disease, including any of the following:
_ hemodynamically significant aortic or mitral valve disease
_ restrictive or congestive cardiomyopathy
_ left ventricular ejection fraction < 40% by
- multigated radionucleotide angiogram (MUGA), or - angiography, or
- echocardiography
_ unstable angina pectoris
_ life-threatening cardiac arrhythmias
10. Chronic bleeding disorders
11. Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
12. Women who are pregnant or breast-feeding
13. 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
14. Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months
15. Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization
Patients who are found to be unfit for participation in this study by the doctor-in-charge.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyaji Katsumasa |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
Homepage URL
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Actelion Pharmaceuticals Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 17 | Day |
Last modified on
| 2012 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007963
