Hypertension, PulmonaryPhase 3NCT01959828
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
A Phase 3 study testing IK-3001 in people with Hypertension, Pulmonary and Ventricular Dysfunction, Left, run by Mallinckrodt at 7 sites in Japan.
Trial summary
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Hypertension, Pulmonary, Ventricular Dysfunction, Left
- What is being tested?
- IK-3001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesJapan
- Study dates
- Sep 2013to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet one of the following criteria:
- Adults, aged 15 to 80 years, with severe congestive heart failure (CHF) and scheduled for left ventricular assist device (LVAD) placement; or
- Children, aged < 15 years, scheduled for surgery for congenital heart disease which may associate pulmonary hypertension (PH)(including children with severe PH due to congenital heart failure and with severe hypoxemia secondary to high pulmonary vascular resistance or either a history or a possibility of developing PH crisis, who are deemed by an investigator or subinvestigator to require IK-3001 pre-operatively); or
- Children, aged < 15 years, with congenital heart disease and scheduled for Glenn surgery; or
- Children, aged < 15 years, with congenital heart disease and scheduled for Fontan surgery.
- For women of childbearing potential, a negative result for a pregnancy test documented prior to enrollment.
- Subjects must give written informed consent. If the subject is a minor the subject's legally acceptable representative (parent or legal guardian) must give written informed consent.
Who cannot join
- Lung hypoplasia or other pre-existing severe lung disease;
- Planned bi-ventricular support;
- Participation in another clinical trial of an investigational agent within 28 days from the day of informed consent for this study including subjects who are deemed to carry a residual effect of an investigational product lasting more than 28 days from a previous investigational study;
- Subjects with PH secondary to organic obstructive lesions in pulmonary arteries;
- Subjects not under mechanical ventilation;
- Investigator or subinvestigator decision that the subject is unsuitable for this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Osaka University Hospital
Osaka, 565-0871
National Cerebral and Cardiovascular Center (Pediatric CV Surgery)
Osaka, 565-8565
National Cerebral and Cardiovascular Center (Transplantation)
Osaka, 565-8565
The University of Tokyo Hospital
Tokyo, 113-8655
National Center for Child Health and Development
Tokyo, 157-8535
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
Tokyo Metropolitan Children's Medical Center
Tokyo, 183-8561
About this study
Official title: Examination of Safety and Effectiveness of IK-3001 (Nitric Oxide for Inhalation) in Japanese Subjects With Pulmonary Hypertension Associated With Cardiac Surgery - Multi-Center, Open-Label, Clinical Study
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
Read the detailed description
This is a multi-center, open-label, clinical study of the safety and efficacy of IK-3001 in 16 subjects with peri- and post-operative pulmonary hypertension associated with cardiac surgery. Two primary sub-sets of this patient population will be evaluated in this study:
- Adults with severe congestive heart failure having LVAD implant
- Children requiring surgery for congenital heart disease with corresponding PH or having Glenn surgery or Fontan surgery for single-ventricle physiology. Children with severe pulmonary hypertension due to congenital heart disease who require inhaled nitric oxide (iNO) pre-operatively may also be enrolled.
- Being tested
- IK-3001
- Keywords
- pulmonary hypertension, cardiac surgery, Glenn surgery, fontan surgery, left ventricular assist device, LVAD
- Medical subject headings
- Hypertension, Pulmonary, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IK-3001Drug
Also called inhaled nitric oxide
| Study group | Role | What they receive |
|---|---|---|
| inhaled nitric oxide | Experimental | Adults: IK-3001 at start dose 20 ppm; may be increased to 40 ppm at the investigator's or subinvestigator's discretion (up to ~ 24 hrs).
Children: IK 3001 at start 10 dose ppm; may be increased to 20 ppm at the investigator's or subinvestigator's discretion (up to ~24 hrs).
Treatment with IK-3001 will continue until it is clinically indicated to begin the weaning process from IK-3001. Receives: Drug: IK-3001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pulmonary artery pressure (mPAP) in Adult subjects (with LVAD)
Measured: Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Adult subjects (with LVAD)
Measured: Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Change in central venous pressure (CVP) in Children (with congenital heart disease)
Measured: Predose baseline to 24 hours (or final observation, if < 24 hours)(measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Children (with congenital heart disease)
Measured: Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khurram Jamil, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959828
- Sponsor's protocol ID
- IK-3001-CVS-301
- Status last verified
- Sep 2016
- First submitted
- 8 Oct 2013
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Safety and Effectiveness of IK-3001 (Nitric Oxide for Inhalation) in Japanese Subjects With Pulmonary Hypertension Associated With Cardiac Surgery - Multi-Center, Open-Label, Clinical Study
- ClinicalTrials.gov ID
- NCT01959828
- Acronym / sponsor ID
- IK-3001-CVS-301
- Keywords
- pulmonary hypertension, cardiac surgery, Glenn surgery, fontan surgery, left ventricular assist device, LVAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
Detailed description
This is a multi-center, open-label, clinical study of the safety and efficacy of IK-3001 in 16 subjects with peri- and post-operative pulmonary hypertension associated with cardiac surgery. Two primary sub-sets of this patient population will be evaluated in this study:
- Adults with severe congestive heart failure having LVAD implant
- Children requiring surgery for congenital heart disease with corresponding PH or having Glenn surgery or Fontan surgery for single-ventricle physiology. Children with severe pulmonary hypertension due to congenital heart disease who require inhaled nitric oxide (iNO) pre-operatively may also be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhaled nitric oxide | Experimental | Drug: IK-3001Adults: IK-3001 at start dose 20 ppm; may be increased to 40 ppm at the investigator's or subinvestigator's discretion (up to ~ 24 hrs). Children: IK 3001 at start 10 dose ppm; may be increased to 20 ppm at the investigator's or subinvestigator's discretion (up to ~24 hrs). Treatment with IK-3001 will continue until it is clinically indicated to begin the weaning process from IK-3001. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must meet one of the following criteria:
- For women of childbearing potential, a negative result for a pregnancy test documented prior to enrollment.
- Subjects must give written informed consent. If the subject is a minor the subject's legally acceptable representative (parent or legal guardian) must give written informed consent.
Key exclusion criteria (6 listed)
- Lung hypoplasia or other pre-existing severe lung disease;
- Planned bi-ventricular support;
- Participation in another clinical trial of an investigational agent within 28 days from the day of informed consent for this study including subjects who are deemed to carry a residual effect of an investigational product lasting more than 28 days from a previous investigational study;
- Subjects with PH secondary to organic obstructive lesions in pulmonary arteries;
- Subjects not under mechanical ventilation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IK-3001Also: inhaled nitric oxide | Drug | inhaled nitric oxide |
Primary outcome
Change in mean pulmonary artery pressure (mPAP) in Adult subjects (with LVAD)
Time frame: Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Adult subjects (with LVAD)
Time frame: Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Change in central venous pressure (CVP) in Children (with congenital heart disease)
Time frame: Predose baseline to 24 hours (or final observation, if < 24 hours)(measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Children (with congenital heart disease)
Time frame: Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khurram Jamil, MD study director
Mallinckrodt
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IK-3001 in people with Hypertension, Pulmonary and Ventricular Dysfunction, Left, run by Mallinckrodt at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean pulmonary artery pressure (mPAP) in Adult subjects (with LVAD) (time frame: Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.