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NCT01894022 · ClinicalTrials.gov registry record · Phase 3
A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT01894022: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT01894022 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01894022, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: the product is approved locally for use in inoperable CTEPH patients; development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities; or the investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.
Primary Outcome
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Refer to the general AE/SA
Interventions
- DRUG Ambrisentan 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-01-23 |
| Est. Completion | 2015-11-18 |
| Phase | Phase 3 |
Why NCT01894022 stopped before completion
NCT01894022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Ambrisentan 5 mg is the first listed.
NCT01894022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01894022 about?
NCT01894022 is a clinical study titled "A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)". This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: the product is approved locally for use in inoperable CTEPH p...
What is the current status of trial NCT01894022?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2014-01-23. Estimated completion is 2015-11-18.
What interventions are being tested in trial NCT01894022?
The interventions under investigation include: Ambrisentan 5 mg (DRUG).
Who is sponsoring clinical trial NCT01894022?
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 NCT01894022's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 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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