PAHPhase 2PAHNCT03449524
PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
A Phase 2 study testing 75mg CXA-10 and 150mg CXA-10 in people with PAH, run by Complexa, Inc. at 46 sites in 2 countries.
Trial summary
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PAH
- What is being tested?
- 75mg CXA-10 and 150mg CXA-10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 1 Aug 2018to 5 Aug 2020
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 to 80 years of age inclusive at Screening
- Weight ≥40 kg
- Must have a diagnosis of WHO Group 1 PH
- Have a World Health Organization (WHO) Classification of Functional Status Class II or III of patients with PH
- Must meet hemodynamic criteria by means of a right heart catheterization
- Meet pulmonary function test parameters
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- A 6 MWD test of ≥125m and ≤550m at the visit
- Subjects must have a resting arterial oxygen saturation (SaO2) ≥90%, with or without supplemental oxygen, as measured by pulse oximetry at Screening
- Subjects enrolled in a prescribed exercise program for pulmonary rehabilitation must be in a stable program for 3 months prior to Screening (Visit 1) and must agree to maintain their current level of rehabilitation throughout the study. If subjects are not enrolled in a prescribed exercise training program for pulmonary rehabilitation, they cannot enroll during the Screening/Baseline Period or throughout the study
- If receiving simvastatin-containing products: dose should not exceed 20 mg/day
- Subjects must be receiving no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonist (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists and must be on stable doses (≥3 months) at Screening (Visit 1)
Who cannot join
- Contraindications for CMRI imaging
- WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension
- Unrepaired congenital heart defects and significant congenital heart defects (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of Pulmonary Hypertension)
- QTcF > 500 msec
- Acute myocardial infarction or acute coronary syndrome within the last 90 days
- Cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days
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- Hospitalization for left heart failure within the last 90 days
- Clinically significant aortic or mitral valve disease defined as greater than mild regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive cardiomyopathy; left ventricular dysfunction (LVEF < 50%); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid depletion
- Chronic atrial fibrillation and life-threatening cardiac arrhythmias
- Personal or family history of congenital prolonged QTc syndrome or sudden or sudden unexpected death due to a cardiac reason
- Clinically significant anemia
- Severe hepatic impairment or active chronic hepatitis
- Receiving intravenous inotropes within 2 weeks prior to Screening
- History of angina pectoris or other condition that was treated with long or short acting nitrates <12 weeks of Screening
- Received prednisone doses >15mg/day or changes in immunosuppressive medications < 12 weeks prior to Screening (Visit 1)
- Recent (within 1 year) history of abusing alcohol or illicit drugs.
- History of any primary malignancy, with no evidence of disease for at least 5 years
- Treatment with any investigational drug or device within 30 days or 5 half-lives
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States40 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
University of Colorado Health
Aurora, Colorado, 80045
University of Alabama
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115-6110
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
Christ Hospital-Lindner Research Center
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
UT Southwestern
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Duke University
Durham, North Carolina, 27710
Texas Tech
El Paso, Texas, 79905
Inova Medical Campus
Falls Church, Virginia, 22042
University of Florida Health
Gainesville, Florida, 32608
Penn State M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Houston Methodist
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
University of Kansas
Kansas City, Kansas, 66160
Loyola University
Maywood, Illinois, 60153-3328
University of Miami
Miami, Florida, 33136
Froedert Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesotta
Minneapolis, Minnesota, 55455
Vanderbuilt University
Nashville, Tennessee, 37232
NYU Langone Medical Center
New York, New York, 10279
Sentara Medical Group
Norfolk, Virginia, 23507
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
AdventHealth
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of California San Francisco
San Francisco, California, 94143-2202
Washington University and Barnes Jewish Hospital
St Louis, Missouri, 63110
University of Arizona
Tucson, Arizona, 85724
Washington Hospital (Medstar)
Washington D.C., District of Columbia, 20010
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
United Kingdom6 sites
Golden Jubilee National Hospital
Glasgow, G81 4DY
Royal Free
London, NW3 2QG
Royal Brompton
London, SW3 6HP
Hammersmith Hospital
London, W12 0HS
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Royal Hallamshire Hospital
Sheffield, S10 2JF
About this study
Official title: Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.
Read the detailed description
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.
The study will be performed in approximately 50 study centers across the United States of America and Europe. The recruitment period is anticipated to be approximately 24 months. Approximately 115 subjects will be enrolled to ensure at least 96 subjects complete the study.
Study participation for each subject will last approximately 8 months. The study will consist of a screening period (within 30 days prior to dosing), 180 days (approximately 6 months) treatment period and approximately 14 days follow-up period after the end of treatment visit.
- Conditions
- PAH
- Being tested
- 75mg CXA-10, 150mg CXA-10, Placebo
- Keywords
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, PAH, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Cardiac MRI, Right Ventricular Function, Hypertension, Familial Primary Pulmonary Hypertension, Connective Tissue Diseases, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Hypertension, Familial Primary Pulmonary Hypertension, Connective Tissue Diseases, Vascular Diseases, Cardiovascular Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75mg CXA-10Drug
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
150mg CXA-10Drug
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 75mg CXA-10 | Active comparator | Once daily dosing of 75mg CXA-10 in the morning Receives: Drug: 75mg CXA-10 |
| 150mg CXA-10 | Active comparator | Once daily dosing of 150mg CXA-10 in the morning Receives: Drug: 150mg CXA-10 |
| Placebo | Placebo comparator | Once daily dosing in the morning Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Ventricular Ejection Fraction (RVEF)
- To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by right ventricular ejection fraction (RVEF) as measured by Cardiac MRI
Measured: 6 months
Pulmonary Vascular Resistance (PVR)
- To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by pulmonary vascular resistance (PVR) as measured by right heart catheterization (RHC)
Measured: 6 months
Secondary outcomes (1)
6 Minute Walk Distance (6MWD)
To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by 6 minute walk distance (6MWD)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Aug 2018
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Why it stopped: LOE
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAHStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CXA-10
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Philips Healthcare, Cardiovascular Clinical Sciences Inc, MicroConstants, Innovative Analytics, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Responsible party
- Sponsor
- Investigators
- Theo Danoff, MD, Study director, Complexa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449524
- Sponsor's protocol ID
- CXA-10-301
- Acronym
- PAH
- Status last verified
- Aug 2020
- First submitted
- 14 Feb 2018
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT03449524
- Acronym / sponsor ID
- PAH / CXA-10-301
- Conditions
- PAH
- Keywords
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, PAH, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Cardiac MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: LOE
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Complexa, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Philips Healthcare, Cardiovascular Clinical Sciences Inc, MicroConstants, Innovative Analytics, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 28 Feb 2018 (actual)
- 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.
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.
Detailed description
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.
The study will be performed in approximately 50 study centers across the United States of America and Europe. The recruitment period is anticipated to be approximately 24 months. Approximately 115 subjects will be enrolled to ensure at least 96 subjects complete the study.
Study participation for each subject will last approximately 8 months. The study will consist of a screening period (within 30 days prior to dosing), 180 days (approximately 6 months) treatment period and approximately 14 days follow-up period after the end of treatment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- CXA-10
| Arm | Type | Receives |
|---|---|---|
| 75mg CXA-10 | Active comparator | Drug: 75mg CXA-10Once daily dosing of 75mg CXA-10 in the morning |
| 150mg CXA-10 | Active comparator | Drug: 150mg CXA-10Once daily dosing of 150mg CXA-10 in the morning |
| Placebo | Placebo comparator | Other: PlaceboOnce daily dosing in the morning |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females between 18 to 80 years of age inclusive at Screening
- Weight ≥40 kg
- Must have a diagnosis of WHO Group 1 PH
- Have a World Health Organization (WHO) Classification of Functional Status Class II or III of patients with PH
- Must meet hemodynamic criteria by means of a right heart catheterization
Key exclusion criteria (18 listed)
- Contraindications for CMRI imaging
- WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension
- Unrepaired congenital heart defects and significant congenital heart defects (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of Pulmonary Hypertension)
- QTcF > 500 msec
- Acute myocardial infarction or acute coronary syndrome within the last 90 days
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 |
|---|---|---|
| 75mg CXA-10CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2) | Drug | 75mg CXA-10 |
| 150mg CXA-10CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2) | Drug | 150mg CXA-10 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Right Ventricular Ejection Fraction (RVEF)
Time frame: 6 months
• To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by right ventricular ejection fraction (RVEF) as measured by Cardiac MRI
Pulmonary Vascular Resistance (PVR)
Time frame: 6 months
• To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by pulmonary vascular resistance (PVR) as measured by right heart catheterization (RHC)
1 secondary outcome
6 Minute Walk Distance (6MWD)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: LOE). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Theo Danoff, MD study director
Complexa, Inc.
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 75mg CXA-10 and 150mg CXA-10 in people with PAH, run by Complexa, Inc. at 46 sites in 2 countries.
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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, United Kingdom. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: LOE). Results are not available in the source record.
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?
Right Ventricular Ejection Fraction (RVEF) (time frame: 6 months). The study lists 2 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 10 Aug 2020.