A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 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 2012-04-30, after 2011-09-30 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 2012-04-30. 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
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Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancercelldlpatientsuln
Phrases that lowered it: tabletdayparticipantcrossoverdose -
Sponsor's past termination rate: 4.1% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 6.9% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 29 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 67.1% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 364 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports before start: 93564 (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 79 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 17156 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: 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
- 79 (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
- 364 (typical: 32)
- Sponsor's past termination rate
- 4.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 29 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 93564 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17156 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- atorvastatin, ezetimibe
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
- A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1) NCT01370603 · started 2011 · scored riskier than 10% of active trials completed
- Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439) NCT03768427 · started 2019 · scored riskier than 23% of active trials completed
- MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162) NCT01154036 · started 2010 · scored riskier than 21% of active trials completed
- Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia NCT01420549 · started 2013 · scored riskier than 34% of active trials completed
- Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) NCT01335997 · started 2011 · scored riskier than 23% of active trials terminated
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.