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NCT01884675 · ClinicalTrials.gov registry record · Phase 3
Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT01884675 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 33 participants.
The verdict
NCT01884675, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study Summary
It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg) versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.
Interventions
- DRUG Placebo
- DRUG Ambrisentan 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01884675
The ClinicalTrials.gov registry entry for NCT01884675 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01884675 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01884675 about?
NCT01884675 is a clinical study titled "Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.". It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel group, 16 week study will com...
What is the current status of trial NCT01884675?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2013-09. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01884675?
The interventions under investigation include: Placebo (DRUG), Ambrisentan 5 mg (DRUG).
Who is sponsoring clinical trial NCT01884675?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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