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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006740
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007963

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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