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NCT01302444 · ClinicalTrials.gov registry record · Phase 4
Treprostinil Combined With Tadalafil for Pulmonary Hypertension
A Phase 4 study, sponsored by Rhode Island Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT01302444 is a Phase 4 study that was terminated before completion, run by Rhode Island Hospital. The registered enrollment target is 1 participants.
The verdict
NCT01302444, a Phase 4 study, was terminated before completion, sponsored by Rhode Island Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Objectives: To test whether the combined administration of the medications treprostinil(a prostacycline therapy), and tadalafil(a PDE-5 \[ phosphodiesterase type 5\]Inhibitor therapy) is better than the administration of treprostinil alone. This treatment would be offered to newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for this disease and are deemed candidates for the medication treprostinil by their physician. The combination therapy will be compared to single therapy with only treprostinil in a double-blind manner. Current therapy is to begin one treatment, either a PDE5 inhibitor or a prostacycline, depending on the severity of the patient's PAH (pulmonary arterial hypertension) disease and add additional therapies as deterioration occurs. This treatment could add two agents initially. Secondary objectives are: To improve pulmonary arterial pressures as measured through a cardiac echocardiogram, improve the subject's 6minute walk distance, delaying the time to clinical worsening, and lowering plasma BNP levels. Research Procedures: To begin the administration of both treatments at the same time. Time period is 16 weeks with a one- year follow-up. Cardiac Echocardiograms, clinic physician exams, and lab work will be followed. Subjects will be between the ages of 18 - 75.
Interventions
- DRUG Placebo
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01302444
The ClinicalTrials.gov registry entry for NCT01302444 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01302444 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01302444 about?
NCT01302444 is a clinical study titled "Treprostinil Combined With Tadalafil for Pulmonary Hypertension". Objectives: To test whether the combined administration of the medications treprostinil(a prostacycline therapy), and tadalafil(a PDE-5 \[ phosphodiesterase type 5\]Inhibitor therapy) is better than the administration of treprostinil alone. This treatment would be offered to newly diagnosed patients...
What is the current status of trial NCT01302444?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2011-03. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01302444?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT01302444?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
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