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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2023 |
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Main ID: |
NCT02652429 |
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Date of registration:
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17/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
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Scientific title:
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An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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22 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02652429 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Ashika Ahmed, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bellerophon Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed Informed Consent Form prior to the initiation of any study mandated procedures
or assessments.
- PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and
PULSE-PAH-004 and have continued drug/device usage.
- Subjects are willing and considered in the judgement of the Investigator able to use
the INOpulse device continuously for up to 24 hours per day.
- All female subjects must be willing to continue to take adequate precaution to avoid
pregnancy.
- Subjects in need for continued treatment with iNO in the opinion of the treating
physician and agreement from Sponsor.
Exclusion Criteria:
- Subjects who require treatment with riociguat
- Subjects who early discontinued drug/device usage due to withdrawal of consent or an
AE requiring termination from treatment in IK-7001-PAH-201
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Inhaled Nitric Oxide
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Primary Outcome(s)
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Incidence of Serious Adverse Events
[Time Frame: Through Study Completion, anticipated 3 years]
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Incidence of INOpulse device malfunction and/or device failure leading to an AE
[Time Frame: Through Study Completion, anticipated 3 years]
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Secondary ID(s)
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PULSE-PAH-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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