Carvedilol PAH A Pilot Study of Efficacy and Safety
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (141 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2016-06-30, after 2014-05-31 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-06-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectspasthearttolerabilitysignificant
Phrases that lowered it: effect ofthe effectpatientsasthmamm -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 11.8% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 67 (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports marked serious: 68.7% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Sponsor's past termination rate: 8.2% (raises risk) · Sponsor's track record
-
Drug's FAERS reports before start: 33920 (lowers risk) · Drug's FDA history
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
Maximum age: 99 (raises risk) · Who can join
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Primary purpose: basic science (lowers risk) · Design
-
Blinding: none (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 6234 (lowers risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 171 (typical: 32)
- Sponsor's past termination rate
- 8.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 67 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 33920 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6234 (typical: 412.5)
- Drug's FAERS reports marked serious
- 68.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory
- Drugs matched to FDA substances
- carvedilol
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Beta-blockers in Pulmonary Arterial Hypertension NCT02507011 · started 2016 · scored riskier than 60% of active trials terminated
- Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension NCT00964678 · started 2010 · scored riskier than 92% of active trials completed
- A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1) NCT03924154 · started 2019 · scored riskier than 43% of active trials terminated
- A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension NCT01757808 · started 2011 · scored riskier than 86% of active trials completed
- This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT03754660 · started 2019 · scored riskier than 28% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.