Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3)
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (106 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
Completed on 2019-12-31, after 2014-03-31 start.
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 2019-12-31. 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: dlheartventricularcoronarymyocardial
Phrases that lowered it: paindiseaseseffectmmhgscreening -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 14.2% (raises risk) · Sponsor's track record
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Minimum age: 21 (lowers risk) · Who can join
-
Drug's FAERS reports marked serious: 60.0% (lowers risk) · Drug's FDA history
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Phase: 1/2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 188 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 10.6% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 473 (lowers risk) · Sponsor's track record
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Keywords listed: 0 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 90 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 473 (typical: 32)
- Sponsor's past termination rate
- 14.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 188 (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
- 12091 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3087 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, urogenital
- Drugs matched to FDA substances
- tadalafil
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 Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2) NCT01970176 · started 2014 · scored riskier than 65% of active trials completed
- Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure NCT01544998 · started 2012 · scored riskier than 56% of active trials completed
- CR Aim #2 - AT1 Receptor Blockade & ACE Inhibition Effect on Humoral Function NCT01678794 · started 2012 · scored riskier than 77% of active trials completed
- Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure NCT01910389 · started 2013 · scored riskier than 58% of active trials terminated
- Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study) NCT00763867 · started 2008 · scored riskier than 84% 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.