Pulmonary Arterial HypertensionPhase 4NCT00439946
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
A Phase 4 study testing treprostinil and Crono Five ambulatory pump in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 3 sites in United States.
Trial summary
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- treprostinil and Crono Five ambulatory pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Mar 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
- Group 1 pulmonary arterial hypertension
- Idiopathic pulmonary arterial hypertension (IPAH)
- Familial pulmonary arterial hypertension (FPAH)
- Associated pulmonary arterial hypertension (APAH):
Show all 16Show fewer
- collagen vascular disease
- congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry.
- portal hypertension
- drugs and toxins
- Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
- WHO Class II-III
- Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
- Have central intravenous catheter
- Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
- Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Who cannot join
- nursing or pregnant woman
- received a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for pulmonary hypertension added within the last month.
- Had any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
- Had a central venous line infection within the past 30 days.
- Previous documented evidence of significant parenchymal lung disease as evidenced by pulmonary function tests as follows (any one of the following):
Show all 16Show fewer
- Total Lung Capacity ≤ 60% (predicted) or
- If Total Lung Capacity is between 60% and 70% (predicted), a High Resolution Computed Tomography (CT) scan must be performed to rule out diffuse interstitial fibrosis or alveolitis
- History of or evidence of left-sided heart disease
- Having any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis).
- Having a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable.
- Uncontrolled systemic hypertension as evidenced by a systolic blood pressure greater than 160 millimeters of mercury (mmHg) or diastolic blood pressure greater than 100 mmHg.
- Chronic renal insufficiency as defined by serum creatinine greater than 2.5 milligrams per deciliter (mg/dL) or the requirement for dialysis.
- Receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
- Active infection, or any other ongoing condition that would interfere with the interpretation of study assessments.
- The presence of any physiological or psychological condition that contraindicates the administration of Remodulin.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
THE NEW YORK-PRESBYTERIAN HOSPITAL Weill Cornell Medical Center
New York, New York, 10065
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73122
University of California San Francisco (UCSF) Medical Center
San Francisco, California, 94143
About this study
Official title: Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
Read the detailed description
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH, and to improve health related quality of life (HRQOL).
Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the intravenous (IV) and subcutaneous (SC) routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension from the CADD legacy pump to a smaller pump called the Crono Five.
Participation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have 4 visits during the study and will spend at least 1 night in the hospital.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- treprostinil, Crono Five ambulatory pump
- Keywords
- pulmonary hypertension, PAH, Remodulin, treprostinil, Quality of Life, rapid switch
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinilDrug
Also called Remodulin
rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
Crono Five ambulatory pumpDevice
Used for administration of IV Remodulin (treprostinil)
| Study group | Role | What they receive |
|---|---|---|
| treprostinil | Experimental | IV treprostinil continuous infusion via Crono Five infusion pump. Receives: Drug: treprostinil; Device: Crono Five ambulatory pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)
The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002].
Measured: Week 8
Secondary outcomes (13)
Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test
The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).
Measured: Week 8
Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification
WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class.
Measured: Week 8
Change From Baseline at Week 8 in Symptoms of PAH- Fatigue
The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.
Measured: Week 8
Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea
The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.
Measured: Week 8
Change From Baseline at Week 8 in Symptoms of PAH- Edema
The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.
Measured: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Orthopnea
The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.
Measured: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Dizziness
The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.
Measured: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Syncope
The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.
Measured: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Chest Pain
The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.
Measured: Week 8
Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin.
Measured: Week 8
Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0-25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0-30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0-25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous ('True'/'Not true') response options while the Activity/Functioning scale has three-point ('Able to do on own without difficulty'/'Able to do on own with difficulty'/'Unable to do on own') response options. The CAMPHOR score range can be from 0 to 80. A reduction in score denotes improved heath status.
Measured: Baseline and Week 8
Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-question questionnaire that measures the level of satisfaction or dissatisfaction patients have with their study medication in 4 areas: effectiveness (3 questions), side effects (5 questions), convenience (3 questions), and global satisfaction (3 questions). With the exception of the first side effects question (a yes or no question), all items have 5 or 7 responses which are scored from 1 (least satisfied) to 5 or 7 (most satisfied). A total score is then summed for each domain on the following scales: effectiveness 1-21, side effects 1-20, convenience 1-21, and global satisfaction 1-17. The TSQM score range can be from 0 to 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.
Measured: Baseline and Week 8
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2009
- Study completionMar 2011
Why it stopped: Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Remzi Bag, MD, Principal investigator, INTEGRIS Baptist Medical CenterEvelyn Horn, MD, Principal investigator, Weill Medical College of Cornell UniversityTeresa DeMarco, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439946
- Sponsor's protocol ID
- RIV-PH-410
- Status last verified
- Jun 2013
- First submitted
- 22 Feb 2007
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction
- ClinicalTrials.gov ID
- NCT00439946
- Acronym / sponsor ID
- RIV-PH-410
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary hypertension, PAH, Remodulin, treprostinil, Quality of Life, rapid switch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies
- Enrolment
- 8 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Feb 2007 (estimated)
- Results
- Posted 17 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
Detailed description
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH, and to improve health related quality of life (HRQOL).
Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the intravenous (IV) and subcutaneous (SC) routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension from the CADD legacy pump to a smaller pump called the Crono Five.
Participation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have 4 visits during the study and will spend at least 1 night in the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treprostinil | Experimental | Drug: treprostinil, Device: Crono Five ambulatory pumpIV treprostinil continuous infusion via Crono Five infusion pump. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 to 65 years
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
- WHO Class II-III
- Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
- Have central intravenous catheter
Key exclusion criteria (16 listed)
- nursing or pregnant woman
- received a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for pulmonary hypertension added within the last month.
- Had any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
- Had a central venous line infection within the past 30 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 |
|---|---|---|
| treprostinilAlso: Remodulinrapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump | Drug | treprostinil |
| Crono Five ambulatory pumpUsed for administration of IV Remodulin (treprostinil) | Device | treprostinil |
Primary outcome
Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)
Time frame: Week 8
The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002].
13 secondary outcomes
Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test
Time frame: Week 8
Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification
Time frame: Week 8
Change From Baseline at Week 8 in Symptoms of PAH- Fatigue
Time frame: Week 8
Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea
Time frame: Week 8
Change From Baseline at Week 8 in Symptoms of PAH- Edema
Time frame: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Orthopnea
Time frame: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Dizziness
Time frame: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Syncope
Time frame: Week 8
Change From Baseline at Week 8 in PAH Symptoms- Chest Pain
Time frame: Week 8
Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Week 8
Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
Time frame: Baseline and Week 8
Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Baseline and Week 8
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Remzi Bag, MD principal investigator
INTEGRIS Baptist Medical Center
Evelyn Horn, MD principal investigator
Weill Medical College of Cornell University
Teresa DeMarco, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing treprostinil and Crono Five ambulatory pump in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 3 sites in United States.
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 16 inclusion and 16 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline at Week 8 in 6-Minute Walk Distance (6MWD) (time frame: Week 8). 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 3 Jan 2024.