Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (318 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-04-30, after 2015-09-30 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2016-04-30. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heartfailuresubjectssubjectchronic
Phrases that lowered it: open labelcrossoverpatients whoscreeningsequence -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 33.3% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 14.1% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 9 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 79.5% (lowers risk) · Drug's FDA history
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Drugs with FDA adverse-event history: 4 (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
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 9 (typical: 32)
- Sponsor's past termination rate
- 33.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 16538 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3142 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- hydralazine, hydralazine isosorbide dinitrate, isosorbide, isosorbide dinitrate
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
- Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients NCT03276728 · started 2016 · scored riskier than 16% of active trials terminated
- A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) NCT05532046 · started 2022 · scored riskier than 76% of active trials terminated
- Phase Ib/IIa Trial With AC01 in Patients With HFrEF NCT05642507 · started 2023 · scored riskier than 35% of active trials completed
- A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure NCT02157506 · started 2014 · scored riskier than 94% of active trials completed
- Study to Assess the Safety, Tolerability and PK/PD After 4 Weekly SC Injections of PB1046 in Subjects With Stable HFrEF NCT02808585 · started 2016 · scored riskier than 30% 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.