CXA-10 Study in Subjects With Pulmonary Arterial Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04053543 |
Recruitment Status :
Terminated
(LOE)
First Posted : August 12, 2019
Last Update Posted : August 26, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | July 19, 2019 | ||||
First Posted Date ICMJE | August 12, 2019 | ||||
Last Update Posted Date | August 26, 2020 | ||||
Actual Study Start Date ICMJE | August 9, 2019 | ||||
Actual Primary Completion Date | August 12, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | CXA-10 Study in Subjects With Pulmonary Arterial Hypertension | ||||
Official Title ICMJE | A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301 | ||||
Brief Summary | This is a Phase 2, multicenter, open-label extension (OLE) of study CXA-10-301, to evaluate the long term safety and efficacy of daily dosing of CXA-10. | ||||
Detailed Description | This is a Phase 2, multicenter, open-label extension (OLE) of study CXA-10-301, to evaluate the long term safety and efficacy of daily dosing of CXA-10. The study will be performed in approximately 50 study centers across the United States and the United Kingdom, which participated in CXA-10-301. Approximately 96 subjects who completed treatment in CXA-10-301 will be eligible to participate in this OLE study, after completing all Visit 9 (Day 1 and Day 2) assessments in CXA-10-301. Study participation for each subject will last up to approximately 6.5 months. The study will consist of a 6 month open-label treatment period and require 5 clinic visits and 1 telephone visit, including the Baseline Visit completed simultaneously with Visit 9 CXA-10-301, plus a follow-up visit approximately 2 weeks following the last dose of CXA-10. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: CXA-10 Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | PAH | ||||
Intervention ICMJE | Drug: CXA-10
(10-nitro-9(E)-octadec-9enoic acid)
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Study Arms ICMJE | Experimental: 150mg CXA-10
Once daily dosing of 150mg CXA-10 in the morning
Intervention: Drug: CXA-10
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
33 | ||||
Original Estimated Enrollment ICMJE |
96 | ||||
Actual Study Completion Date ICMJE | August 12, 2020 | ||||
Actual Primary Completion Date | August 12, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
21. Newly prescribed drug or increased dose of an existing drug that is known to prolong the QTc interval and has been associated with Torsades de Pointes (TdP) identified in the CredibleMeds.org website list as known risk (KR) of TdP. Note: Stable doses of drugs classified as conditional risk (CR) of TdP or possible risk (PR) of TdP are permitted (i.e., subject has received the same dose and regimen for at least 30 days prior to Baseline with no anticipated changes to the dose or regimen during the course of the study). 22. Currently taking dimethyl fumarate (Tecfidera™). 23. Any of the following laboratories abnormal and unresolved in CXA-10-301:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04053543 | ||||
Other Study ID Numbers ICMJE | CXA-10-2302 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Complexa, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Complexa, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Complexa, Inc. | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |