Pulmonary HypertensionPhase 4NCT00373360
Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin
A Phase 4 study testing treprostinil sodium in people with Pulmonary Hypertension, run by United Therapeutics at 1 site in United States.
Trial summary
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- treprostinil sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Diagnosis of Idiopathic or Familial Pulmonary Arterial Hypertension (PAH)or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction (Grade of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins or 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
- Have any other type of PAH due to conditions other than noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease
- Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
- Changes to chronic PAH therapy (i.e., new therapy added within last 30 days[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil] or PAH medication discontinued within 7 days of study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
- Central venous line infection within the past 30 days.
Show all 11Show fewer
- Previous documented evidence of significant parenchymal lung disease
- Evidence or history of left-sided heart disease
- Musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable
- Uncontrolled hypertension, chronic renal insufficiency, or active infection.
- Use of investigational drug within past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on 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 IV and 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. Furthermore, 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 using the CADD legacy pump.
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 Hypertension
- Being tested
- treprostinil sodium
- Keywords
- pulmonary hypertension, PAH, Remodulin, treprostinil, Quality of Life, Rapid Switch
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinil sodiumDrug
Also called Remodulin, Flolan
rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: treprostinil sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.
Measured: Baseline and Week 8
Secondary outcomes (24)
Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8
The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).
Measured: Baseline and Week 8
Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8
Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.
Measured: Baseline and Week 8
Change in Symptoms of Dyspnea From Baseline to Week 8
The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Symptoms of Edema From Baseline to Week 8
The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.
Measured: Baseline to Week 8
Change in Symptoms of Orthopnea From Baseline to Week 8
The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Symptoms of Dizziness From Baseline to Week 8
The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Symptoms of Fatigue From Baseline to Week 8
The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Symptoms of Syncope From Baseline to Week 8
The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Symptoms of Chest Pain From Baseline to Week 8
The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.
Measured: Baseline and Week 8
Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.
Measured: Baseline and Week 8
Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.
Measured: Baseline and Week 8
Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.
Measured: Baseline and Week 8
Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8
The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome.
Measured: Baseline and Week 8
Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8
Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse.
Measured: Baseline and Week 8
Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8
Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more.
Measured: Baseline and Week 8
Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8
Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied.
Measured: Baseline and Week 8
Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Measured: Baseline and Week 8
Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Measured: Baseline and Week 8
Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Measured: Baseline and Week 8
Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Measured: Baseline and Week 8
Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Measured: Baseline and Week 8
Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Measured: Baseline and Week 8
Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2008
- Study completionJan 2008
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omar Minai, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373360
- Sponsor's protocol ID
- RIV-PH-411
- Status last verified
- Jan 2013
- First submitted
- 7 Sep 2006
- Last updated
- 7 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. 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) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction
- ClinicalTrials.gov ID
- NCT00373360
- Acronym / sponsor ID
- RIV-PH-411
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, PAH, Remodulin, treprostinil, Quality of Life, Rapid Switch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Posted 7 Jan 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 therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on 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 IV and 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. Furthermore, 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 using the CADD legacy pump.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: treprostinil sodium |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 70 years
- Diagnosis of Idiopathic or Familial Pulmonary Arterial Hypertension (PAH)or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction (Grade of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins or 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
Key exclusion criteria (11 listed)
- Nursing or pregnant woman
- Have any other type of PAH due to conditions other than noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease
- Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
- Changes to chronic PAH therapy (i.e., new therapy added within last 30 days[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil] or PAH medication discontinued within 7 days of study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
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 |
|---|---|---|
| treprostinil sodiumAlso: Remodulin, Flolanrapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump | Drug | 1 |
Primary outcome
Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.
Time frame: Baseline and Week 8
24 secondary outcomes
Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8
Time frame: Baseline and Week 8
Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Symptoms of Dyspnea From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Symptoms of Edema From Baseline to Week 8
Time frame: Baseline to Week 8
Change in Symptoms of Orthopnea From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Symptoms of Dizziness From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Symptoms of Fatigue From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Symptoms of Syncope From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Symptoms of Chest Pain From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- 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.
Omar Minai, MD principal investigator
The Cleveland Clinic
1 site 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 sodium in people with Pulmonary Hypertension, run by United Therapeutics at 1 site 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 7 inclusion and 11 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 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Jan 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 in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8. (time frame: Baseline and 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 7 Jan 2013.