Last updated: 11/03/2018 17:50:21
Study of a new thermo stable formulation of epoprostenol sodium to treat Pulmonary Arterial Hypertension (PAH)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects with Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a registered trademark of the GlaxoSmithKline group of companies.)
Trial description: The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)
Change from Baseline in Study Specific Participant Acceptance Survey
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).
Change from Baseline in dose of thermo stable epoprostenol sodium at Week 4
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4
Secondary outcomes:
Number of Participants With Any treatment emergent Adverse Events (AEs) and treatment emergent Serious Adverse Events(SAEs)
Timeframe: Up to visit 3 (Week 4)
Number of participants with Infusion site reactions during treatment period
Timeframe: Baseline visit (Visit 2) to Week 4 (Visit 3)
Change from Baseline in Vital signs at Week 4 : systolic and diastolic blood pressure
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)
Change from Baseline in Vital signs at Week 4: heart rate
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4
Number of participants with abnormal clinical chemistry
Timeframe: Up to 1 week after Week 4 (Follow-up)
Number of participants with abnormal hematology
Timeframe: Up to 1 week after Week 4 (Follow-up)
Number of participants with abnormal urinalysis
Timeframe: Up to 1 week after Week 4 (Follow-up)
Change from Baseline in Six minute walk distance test (6MWD) after 4-weeks of treatment
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4
Breathlessness after 6MWD – Borg Dyspnoea Index (BDI)
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4
World Health Organization [WHO] functional class at Baseline and after 4- weeks of treatment
Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4
Mean Oxygen saturation in blood over time
Timeframe: up to the treatment follow up (1 week after Visit 3 [Week 4])
Number of participants with Urine pregnancy test positive
Timeframe: up to the treatment follow up (1 week after Visit 3 [Week 4])
Interventions:
Drug: current marketed FLOLAN (epoprostenol sodium)
Drug: new thermo stable formulation of epoprostenol sodium
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
2012-16-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hypertension, Pulmonary
Product
epoprostenol
Collaborators
Not applicable
Study date(s)
November 2011 to November 2012
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Adult male or female at least 18 to 75 years at the time of screening.
- Subjects must have been on FLOLAN (epoprostenol sodium) therapy for pulmonary arterial hypertension (PAH) as approved in the product label.
- Subjects who are given FLOLAN (epoprostenol sodium) for a condition or in a manner that is outside the approved indication.
- Subjects with congestive heart failure arising from severe left ventricular dysfunction.
Inclusion and exclusion criteria
Inclusion criteria:
- Adult male or female at least 18 to 75 years at the time of screening.
- Subjects must have been on FLOLAN (epoprostenol sodium) therapy for pulmonary arterial hypertension (PAH) as approved in the product label.
- Subjects must be on stable doses of their existing FLOLAN (epoprostenol sodium) treatment for a minimum of 3 months prior to screening.
- Subjects must be on stable doses of any current PAH treatments other than FLOLAN (epoprostenol sodium) in the last 30 days.
- Subjects must walk a distance of at least 150 meters during six-minute walk distance test (6MWD). This test must be completed during the Screening Visit.
- A female subject is eligible to participate if she is of non-childbearing potential or of childbearing potential, has a negative pregnancy test at screen, and agrees to use one of the contraception methods listed in the protocol.
- Subjects must be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent form and must sign the form prior to the initiation of any study procedures.
Exclusion criteria:
- Subjects who are given FLOLAN (epoprostenol sodium) for a condition or in a manner that is outside the approved indication.
- Subjects with congestive heart failure arising from severe left ventricular dysfunction.
- Subjects, with or without supplemental oxygen, who have a resting arterial oxygen saturation (SaO2) <90% as measured by pulse oximetry at screening.
- Subjects have been hospitalized as an emergency or visited the emergency room for a condition related to PAH or treatment for PAH in the last 3 months.
- The subject’s clinical condition is such that they are not expected to remain clinically stable for the duration of the study.
- Female subjects who are pregnant or breastfeeding.
- Subjects who have demonstrated noncompliance with previous medical regimens.
- Subjects who have a history of abusing alcohol or illicit drugs within 1 year.
- Subjects with a diagnosis of active hepatitis (hepatitis B surface antibody and hepatitis C antibody).
- Subjects who have participated in a clinical study involving another investigational drug or device within four weeks before screening.
- Subjects who had history malignancies within the past 5 years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- Any concurrent condition that would affect the safety of the subject or in the opinion of the investigator it is not in the best interest of the patient to participate in the study.
Trial location(s)
Location
GSK Investigational Site
Miami Beach, Florida, United States, 33140
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75390-8550
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118-2393
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21205
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-16-05
Actual study completion date
2012-08-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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