Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State
Model scores of the 29,894 trials active now.
Model score 2% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-12-19, after 2018-09-07 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 2018-12-19. 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) (lowers risk) · Wording
Phrases that raised it: statusdefinedpriortherapyto determine
Phrases that lowered it: healthyvolunteersadministrationcrossovervolunteer -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 8.5% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 55 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers 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 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (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
- 3 (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
- 11170 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2178 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- telmisartan
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
- Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use NCT01344629 · started 2011 · scored riskier than 1% of active trials completed
- Bioequivalence of Telmisartan as Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets in Healthy Male Volunteers NCT02276391 · started 2008 · scored riskier than 1% of active trials completed
- Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers NCT02261129 · started 2008 · scored riskier than 1% of active trials completed
- To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers NCT02579356 · started 2014 · scored riskier than 2% of active trials completed
- Telmisartan and Amlodipine Versus Monocomponent Tablets NCT01278797 · started 2011 · scored riskier than 0% 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.