UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042159 |
|---|---|
| Receipt number | R000048125 |
| Scientific Title | A study to evaluate the long-term effect of Endothelin Receptor Antagonist(ERA) in patients with pulmonary hypertension related with COPD and IPF, respectively. |
| Date of disclosure of the study information | 2020/10/19 |
| Last modified on | 2024/01/11 15:23:27 |
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Basic information
Public title
A study to evaluate the long-term effect of Endothelin Receptor Antagonist(ERA) in patients with pulmonary hypertension related with COPD and Idiopathic interstitial pneumonia (IIPs), respectively.
Acronym
A study to evaluate the long-term effect of Endothelin Receptor Antagonist(ERA) in patients with pulmonary hypertension related with COPD and IPF, respectively.
Scientific Title
A study to evaluate the long-term effect of Endothelin Receptor Antagonist(ERA) in patients with pulmonary hypertension related with COPD and IPF, respectively.
Scientific Title:Acronym
A study to evaluate the long-term effect of Endothelin Receptor Antagonist(ERA) in patients with pulmonary hypertension related with COPD and IIPS, respectively.
Region
| Japan |
Condition
Condition
Patients with COPD or IIPs (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<90mmHg or after 6minutes walk), who provide their informed consent to participate in this study.
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term effect of Endothelin Receptor Antagonist(ERA) on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with pulmonary hypertension related with COPD and Idiopathic interstitial pneumonia (IIPs), respectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Influence on survival rate.
Key secondary outcomes
(1) Influence on ADL and Exercise tolerance
(2) Influence on cardiac function
Change in NT-proBNP or BNP etc, and cardiac function, and these association with ADL, survival rate, or severity of PH.
(3) Influence on PFT
Change in %DLco and so on, and these association with ADL, survival rate, or severity of PH
(4)change from baseline in TEI index and so on (including changes in ICT, ET, IRT,RA size, RV size, and TAPSE etc,) on echocardiography and results of Right heart catheter, and these association with ADL, or severity of PH.
(5) Safety of the drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treated subgroup
In patients with COPD without hypoxia (PaO2<60mmHg at rest) (WHO functional class II, III or IV), patients with borderline or less severe pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 15subjects
Tracleer, Voriblis or Opsumit Tablets will be administered basically according to the approved dosage and administration. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition.
Duration of study drug administration: 24 months
Interventions/Control_2
Untreated subgroup
In patients with COPD without hypoxia (PaO2<60mmHg at rest) (WHO functional class II, III or IV), patients with borderline or less severe pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 15subjects
Duration of study: 24 months
Interventions/Control_3
Treated subgroup
In patients with IIPs without hypoxia (PaO2<60mmHg at rest) (WHO functional class II, III or IV), patients with severe pulmonary hypertension with mPAP at rest=/>35mmHg : 10subjects
Tracleer or Opsumit Tablets will be administered basically according to the approved dosage and administration. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition.
Duration of study drug administration: 24 months
Interventions/Control_4
Treated subgroup
In patients with IIPs without hypoxia (PaO2<60mmHg at rest) (WHO functional class II, III or IV), patients with borderline or less severe pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 50subjects
Tracleer or Opsumit Tablets will be administered basically according to the approved dosage and administration. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition.
Duration of study drug administration: 24 months
Interventions/Control_5
Untreated subgroup
In patients with IIPs without hypoxia (PaO2<60mmHg at rest) (WHO functional class II, III or IV), patients with severe pulmonary hypertension with mPAP at rest=/>35mmHg : 10subjects
Duration of study drug administration: 24 months
Interventions/Control_6
Untreated subgroup
In patients with IIPs without hypoxia (PaO2<60mmHg at rest) (WHO functional class II, III or IV), patients with borderline or less severe pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 50subjects
Duration of study drug administration: 24 months
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) Patients having COPD or IIPs aged 20 years and older (males and females)
2) Patients diagnosed at this hospital as having pulmonary hypertension in patients with COPD or IIPs without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV).
3) Patients in a stable disease condition who did not require any change of treatment during the 3 months or more previous to their enrollment.
4) Inpatients and outpatients
5) Patients who provide their written informed consent to participate in this study
Key exclusion criteria
1) Patients already on Endothelin Receptor Antagonist or other drugs for pulmonary hypertension
2) Patients with any disease that can cause right heart overload
3) Patients with hypoxemia (PaO2<60mmHg at rest ).
4) Women who are pregnant or who may be pregnant, and lactating women
5) Patients with moderate or severe liver disorder
6) Patients under treatment with ciclosporin, tacrolimus, or glibenclamide
6) Other patients judged by the investigator to be inappropriate as a subject of this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School
Division name
Department of Respiratory Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo, Tokyo, 113-8603, Japan
TEL
03-5814-6266
yosuke-t@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School
Division name
Department of Respiratory Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo, Tokyo, 113-8603, Japan
TEL
03-5814-6266
Homepage URL
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School IRB
Address
1-1-5 Sendagi, Bunkyo, Tokyo, 113-8603, Japan
Tel
03-3822-2131
nms@esct.bvits.com
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
日本医科大学付属病院呼吸器内科
日本医科大学北総病院呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048125
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/01/19 | English protocol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/01/19 | UMIN用data仕様.jmp |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/01/19 | UMIN用.jmp |
