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NCT01178073 · ClinicalTrials.gov registry record · Phase 3
A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 610
- Enrollment target
NCT01178073: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01178073 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 610 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178073, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 610 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.
Primary Outcome
Time to the first adjudicated CF event (death, hospitalization for worsening pulmonary arterial hypertension \[PAH\], disease progression, or unsatisfactory long-term clinical response) after initiating either first-line combination therapy with AMB and TAD or first-line monotherapy with either drug (AMB or TAD) in par. with PAH was assessed. If data was not available for some par. following a loss to follow-up, their event times were treated as censored at their last assessment time for the sta
Interventions
- DRUG tadalafil
- DRUG ambrisentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2010-10-01 |
| Est. Completion | 2014-07-31 |
| Phase | Phase 3 |
What the finished NCT01178073 record still lists
NCT01178073 is an interventional study that assigns participants to a tested intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which tadalafil is the first listed.
NCT01178073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01178073 about?
NCT01178073 is a clinical study titled "A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)". The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure even...
What is the current status of trial NCT01178073?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 610 participants. The study started on 2010-10-01. Estimated completion is 2014-07-31.
What interventions are being tested in trial NCT01178073?
The interventions under investigation include: tadalafil (DRUG), ambrisentan (DRUG).
Who is sponsoring clinical trial NCT01178073?
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 NCT01178073's enrollment target sits among peer trials
610 601st of 2000 higher than 1,399 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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