Cardiovascular DiseaseNCT01387191
Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
An observational study of Cardiovascular Disease, run by GlaxoSmithKline.
Trial summary
The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items; 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Epoprostenol
- Type of treatment
- Injection or infusion
- How many people
- 748 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to Jul 2009
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All Japanese subjects with pulmonary arterial hypertension who are treated with epoprostenol injection
Who may be able to join
- Subjects with cardiovascular disease
Who cannot join
- Subjects with hypersensitivity to epoprostenol
- Subjects with right cardiac failure during an acute exacerbation
- Subjects with severe left ventricular systolic dysfunction
- Subjects with serious left ventricular dysfunction
- Subjects whose pulmonary edema getting worse during dose initiation
About this study
The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;
- Unknown adverse reactions (especially, significant adverse reactions)
- Adverse reaction onset status under practical drug use conditions
- Factors possibly influential on safety
- Factors possibly influential on efficacy
- Patient's prognosis, efficacy and safety in long-term use
- Conditions
- Cardiovascular Disease
- Being tested
- Epoprostenol
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpoprostenolDrug
| Study group | Role | What they receive |
|---|---|---|
| Subjects prescribed epoprostenol | Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period Receives: Drug: Epoprostenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startAug 1999
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387191
- Sponsor's protocol ID
- 112300
- Status last verified
- May 2017
- First submitted
- 30 Jun 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
- ClinicalTrials.gov ID
- NCT01387191
- Acronym / sponsor ID
- 112300
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Jul 2011 (estimated)
- 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.
The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;
- Unknown adverse reactions (especially, significant adverse reactions)
- Adverse reaction onset status under practical drug use conditions
- Factors possibly influential on safety
- Factors possibly influential on efficacy
- Patient's prognosis, efficacy and safety in long-term use
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects prescribed epoprostenol | – | Drug: EpoprostenolSubjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All Japanese subjects with pulmonary arterial hypertension who are treated with epoprostenol injection
Key inclusion criteria (1 listed)
- Subjects with cardiovascular disease
Key exclusion criteria (5 listed)
- Subjects with hypersensitivity to epoprostenol
- Subjects with right cardiac failure during an acute exacerbation
- Subjects with severe left ventricular systolic dysfunction
- Subjects with serious left ventricular dysfunction
- Subjects whose pulmonary edema getting worse during dose initiation
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 |
|---|---|---|
| Epoprostenol | Drug | Subjects prescribed epoprostenol |
Primary outcome
The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by GlaxoSmithKline.
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 1 inclusion and 5 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection (time frame: 12 weeks). 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 16 May 2017.