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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: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT01884675 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 33 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Change from baseline was calculated at Weeks 4, 8, 12 and 16. Change from Baseline was calculated as value at the specified visit minus the Baseline value. Data at Baseline is based on average of two consecutive test results
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 |
Why NCT01884675 stopped before completion
NCT01884675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01884675 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01884675's enrollment target sits among peer trials
33 1907th of 2000 higher than 92 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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