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NCT00840463 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT00840463 is a Phase 4 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 4 participants.
The verdict
NCT00840463, a Phase 4 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a randomized study of ambrisentan that will last 16 weeks. The study will include patients with diastolic heart failure and pulmonary hypertension. Patients will be randomized (1:1) to ambrisentan or placebo. The ambrisentan or matching placebo will be started at 2.5 mg by mouth daily and increased to 5mg and then 10mg daily, if tolerated. Patients will be seen at least monthly for 16 weeks. Adverse reactions will be reviewed and the required monthly laboratory tests (liver function testing and pregnancy testing, if applicable), will be performed. Patients will also complete an exercise test (six minute walk distance) and a quality of life survey at the baseline, week 4 and week 16 visit. An echocardiogram and a right heart catheterization and left ventricular end diastolic pressure measurement will be performed at the 16 week visit. The primary end-point is safety, and secondary end-points include the catheterization results, echocardiogram results, the walk distance and the quality of life survey. The expected completion of the study is 18 months from initiation. Ambrisentan is an FDA approved drug for PAH, but not for CHF.
Interventions
- OTHER Placebo
- DRUG Ambrisentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2009-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00840463
The ClinicalTrials.gov registry entry for NCT00840463 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00840463 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00840463 about?
NCT00840463 is a clinical study titled "Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan". This is a randomized study of ambrisentan that will last 16 weeks. The study will include patients with diastolic heart failure and pulmonary hypertension. Patients will be randomized (1:1) to ambrisentan or placebo. The ambrisentan or matching placebo will be started at 2.5 mg by mouth daily and in...
What is the current status of trial NCT00840463?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2009-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00840463?
The interventions under investigation include: Placebo (OTHER), Ambrisentan (DRUG).
Who is sponsoring clinical trial NCT00840463?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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