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NCT01042158 · ClinicalTrials.gov registry record · Phase 4
A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis
A Phase 4 study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01042158: Completed Phase 4 study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, sponsored by Johns Hopkins University.
NCT01042158 is a Phase 4 study of Pulmonary Hypertension and Pulmonary Arterial Hypertension that has completed, run by Johns Hopkins University. The registered enrollment target is 25 participants, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01042158, a Phase 4 study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
Primary Outcome
Assessment of change in Right ventricular mass was done via standard volumetric cine images of the right heart at baseline and comparing it to that at the end of 36 weeks using Cardiac Magnetic Resonance Imaging studies.
Conditions Studied
Interventions
- DRUG tadalafil and ambrisentan upfront combination therapy
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT01042158 record still lists
NCT01042158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Pulmonary Hypertension appearing as the primary indexed condition, and to 1 intervention - of which tadalafil and ambrisentan upfront combination therapy is the first listed.
NCT01042158 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01042158 about?
NCT01042158 is a clinical study titled "A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis". This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6...
What is the current status of trial NCT01042158?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2010-01. Estimated completion is 2014-11.
What conditions does trial NCT01042158 study?
This clinical trial studies the following conditions: Pulmonary Hypertension, Pulmonary Arterial Hypertension, Systemic Sclerosis, Connective Tissue Disease, Scleroderma Spectrum of Diseases.
What interventions are being tested in trial NCT01042158?
The interventions under investigation include: tadalafil and ambrisentan upfront combination therapy (DRUG).
Who is sponsoring clinical trial NCT01042158?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01042158 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01042158's enrollment target sits among peer trials
25 51st of 72 higher than 20 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension 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.
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