Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01462565
• Date of registration: 13/10/2011
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)
• Scientific 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.)
• Date of first enrolment: November 1, 2011
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01462565
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, Netherlands, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: new thermo stable formulation of epoprostenol sodium

Drug: current marketed FLOLAN (epoprostenol sodium)

Primary Outcome(s)

Change From Baseline in Study Specific Participant Acceptance Survey [Time Frame: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).]

Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) [Time Frame: 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 [Time Frame: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4]

Secondary Outcome(s)

Breathlessness After 6MWD - Borg Dyspnoea Index (BDI) [Time Frame: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4]

Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure [Time Frame: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)]

World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment [Time Frame: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4]

Number of Participants With Abnormal Urinalysis [Time Frame: Up to 1 week after Week 4 (Follow-up)]

Number of Participants With Abnormal Hematology [Time Frame: Up to 1 week after Week 4 (Follow-up)]

Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment [Time Frame: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4]

Number of Participants With Urine Pregnancy Test Positive [Time Frame: up to the treatment follow up (1 week after Visit 3 [Week 4])]

Change From Baseline in Vital Signs at Week 4: Heart Rate [Time Frame: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4]

Number of Participants With Abnormal Clinical Chemistry [Time Frame: Up to 1 week after Week 4 (Follow-up)]

Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) [Time Frame: Up to visit 3 (Week 4)]

Number of Participants With Infusion Site Reactions During Treatment Period [Time Frame: Baseline visit (Visit 2) to Week 4 (Visit 3)]

Mean Oxygen Saturation in Blood Over Time [Time Frame: up to the treatment follow up (1 week after Visit 3 [Week 4])]

Secondary ID(s)

115332

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01462565