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NCT01268553 · ClinicalTrials.gov registry record · Phase 4
Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication
A Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
- 3
- Study locations
NCT01268553: Completed Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
NCT01268553 is a Phase 4 study of Pulmonary Arterial Hypertension that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 6 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01268553, a Phase 4 study of Pulmonary Arterial Hypertension, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to assess tolerability and clinical effects of transition from intravenous (IV, needle in the vein) or subcutaneous (SQ, needle in the skin) to the recently-approved inhaled treprostinil (Tyvaso) for the treatment of pulmonary arterial hypertension (PAH). Our hypothesis is that the transition to inhaled treprostinil will be tolerated by patients. The intravenous and subcutaneous drugs epoprostenol and treprostinil received approval for treatment of PAH many years ago. While these medications improve exercise capacity and the symptoms of PAH, they are given by injection and thus have several side effects, such as pain and catheter infection. This has resulted in many patients either refusing to take the medication or quitting these medications because of not tolerating them. The only other form of prostacyclin treatment available for PAH patients is inhaled. There are 2 inhaled prostacyclins approved for PAH, however one of these requires at least 6 inhalations per day, every day, and takes about 30 minutes to inhale each time. Thus, it has not been a regularly-used medication and issues surrounding compliance make it a riskier drug to use if patients do not get their full doses every day. The other inhaled medication, treprostinil, was approved a few months ago, only needs to be given 4 times a day, and takes about 2-3 minutes to inhale. Since inhaled treprostinil can be administered easily, it is anticipated that many patients will transition from epoprostenol or treprostinil to the recently approved inhaled treprostinil, however we do not know if this is a safe or effective way to manage patients. Thus, the goal of this prospective study is to gather observational data regarding how that switch is made, tolerability of the switch, and, to the extent possible with this methodology, assess clinical effects of the switch. This is a prospective study. Twenty patients \> 18 years old with PAH will be enrolled. Patients enrolled will be
Primary Outcome
The number of adverse events will be recorded at transition, 4 weeks, and 12 weeks.
Conditions Studied
Interventions
- DRUG Treprostinil
Study Locations (3)
California
- University of CA, San Francisco - San Francisco
- Harbor-UCLA Medical Center - Torrance
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-08 |
| Est. Completion | 2016-10-05 |
| Phase | Phase 4 |
What the finished NCT01268553 record still lists
NCT01268553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Treprostinil is the first listed.
NCT01268553 reports a single indexed study location in California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01268553 about?
NCT01268553 is a clinical study titled "Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication". The purpose of this study is to assess tolerability and clinical effects of transition from intravenous (IV, needle in the vein) or subcutaneous (SQ, needle in the skin) to the recently-approved inhaled treprostinil (Tyvaso) for the treatment of pulmonary arterial hypertension (PAH). Our hypothesis...
What is the current status of trial NCT01268553?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2010-08. Estimated completion is 2016-10-05.
What conditions does trial NCT01268553 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT01268553?
The interventions under investigation include: Treprostinil (DRUG).
Who is sponsoring clinical trial NCT01268553?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01268553 being conducted?
This trial has 3 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01268553's enrollment target sits among peer trials
6 62nd of 63 higher than 1 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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