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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 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 19 participants.

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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.

Interventions

  • DRUG Ambrisentan 5 mg

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2014-01-23
Est. Completion 2015-11-18
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01894022

The ClinicalTrials.gov registry entry for NCT01894022 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 19 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 1 intervention - of which Ambrisentan 5 mg is the first listed.

NCT01894022 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.