Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
Model scores of the 29,894 trials active now.
Model score 9% 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 14% of the time (493 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 2012-09-30, after 2008-02-29 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 2012-09-30. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: abtpurposewomenchronicreceiving
Phrases that lowered it: and safetytypemellitussafety ofdiabetes -
Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 6.3% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 45 (lowers risk) · Who can join
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 76.6% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 45 (typical: 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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 30611 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7563 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, metabolic
- Drugs matched to FDA substances
- atorvastatin, choline fenofibrate, fenofibric acid
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
- ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study NCT00673881 · started 2008 · scored riskier than 6% of active trials completed
- Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood NCT00639158 · started 2008 · scored riskier than 16% of active trials completed
- A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease NCT01674712 · started 2012 · scored riskier than 20% of active trials completed
- Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol (Bad Cholesterol) and Triglycerides NCT00812955 · started 2008 · scored riskier than 12% of active trials completed
- Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED) NCT00804843 · started 2009 · scored riskier than 88% 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.