|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000025158 |
|
Date of registration:
|
07/12/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
|
|
Scientific title:
|
A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension - A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension |
|
Date of first enrolment:
|
2016/09/01 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028933 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase III
|
|
|
Countries of recruitment
|
|
Japan,North America,South America,Australia,Europe
| | | | | | | |
|
Contacts
|
|
Name:
|
Yukiko
Hagihara |
|
Address:
|
Harumi Toriton Square Office Tower Y 8F 1-8-11, Harumi, Chuo-ku, Tokyo 104-6108
104-6108
Japan |
|
Telephone:
|
03-6837-9500 |
|
Email:
|
Yukiko.Hagihara@labcorp.com |
|
Affiliation:
|
Labcorp Development Japan K.K. Clinical Development Services |
|
|
Name:
|
Colin
Meyer |
|
Address:
|
2801 Gateway Drive, Suite 150 Irving
Japan |
|
Telephone:
|
1-972-865-2202 |
|
Email:
|
Colin.Meyer@reatapharma.com |
|
Affiliation:
|
Reata Pharmaceuticals Product Development |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1 Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1; 2 Initiation of an exercise program for cardio-pulmonary rehabilitation within 90 days prior to Day1or planned initiation during the study; 3 Stopped receiving any PAH chronic therapy within 60 days prior to Day 1; 4 Stopped receiving any PAH chronic therapy within 60 days prior to Day 1 Received a dose of prednisone 20 mg day (or equivalent dose if other corticosteroid) within 30 days prior to Day 1; 5 Received intravenous or subcutaneous prostacyclin/prostacyclin analogues within 90 days prior to Day 1; 6 Received intravenous inotropes within 30 days prior to Day 1; 7 Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) 160 mm Hg or sitting diastolic BP > 100 mm Hg during Screening after a period of rest 8 Has systolic BP 90 mm Hg during Screening after a period of rest 9 Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following: a Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension; b Pericardial constriction; c Restrictive or congestive cardiomyopathy; d Left ventricular ejection fraction 40% per echocardiogram (ECHO) within 90 days of Day 1; e Symptomatic coronary artery disease within the last 3 years 10 Acutely decompensated heart failure within 30 days prior to Day 1, per investigator assessment 11 Has more than two of the following clinical risk factors for left ventricular diastolic dysfunction: a Age 65 years; b BMI 30 kgm2 c History of systemic hypertension; d History of type 2 diabetes; e History of atrial fibrillation etc
Age minimum:
18years-old
Age maximum:
75years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
|
|
Intervention(s)
|
Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated to a maximum of 10 mg. Dosing period is up to 6 months.
Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 6 months.
|
|
Primary Outcome(s)
|
|
Change from baseline in six-minute-walk distance (6MWD) relative to placebo at Week 24
|
|
Secondary Outcome(s)
|
|
*Improvement by at least one WHO functional class *Increase from baseline in 6MWD by at least 10% *Decrease from baseline in creatine kinase (as a surrogate biomarker for muscle injury and inflammation) by at least 10%
|
|
Secondary ID(s)
|
|
EUDRACT NUMBER: 2016-000196-24
|
|
US IND NUMBER: 119,235
|
|
Source(s) of Monetary Support
|
|
Reata Pharmaceuticals, Inc.
|
|
Ethics review
|
Status: YES
Approval date: 29/07/2016
Contact:
chiken-crc@okayamamc.jp
National Hospital Organization Okayama Medical Center Institutional Review Board
086-294-9911
chiken-crc@okayamamc.jp
|
|