Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health Volunteers

NCT01648231 on ClinicalTrials.gov Phase 1 GlaxoSmithKline (industry) Started 2012-08-06 Completed

Among the lowest-risk 1% of active trials

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 7% of the time (318 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 2012-09-25, after 2012-08-06 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 2012-09-25. 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) (lowers risk) · Wording Phrases that raised it: definedbilirubinpriorsubjectstatus
Phrases that lowered it: healthytabletasthmacrossoverbioavailability
Design: crossover (lowers risk) · Design
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 375 (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Sponsor's past trials: 1636 (raises risk) · Sponsor's track record
Sponsor's past termination rate: 5.0% (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 96362 (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 10.4% (lowers risk) · Drug's FDA history
Blinding: none (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 77.0% (lowers risk) · Drug's FDA history
Disease area, cardiovascular: Yes (raises risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Disease area, psychiatry: No (lowers risk) · Disease area
Maximum age: 65 (lowers 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: 1 (typical: 2)
Number of arms: 3 (typical: 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: 1

Who can join

Minimum age: 18
Maximum age: 65 (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: 1636 (typical: 32)
Sponsor's past termination rate: 5.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 375 (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: 96362 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 21838 (typical: 412.5)
Drug's FAERS reports marked serious: 77.0% (typical: 85.6%)
Drug's FAERS reports with a death: 10.4% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
Drugs matched to FDA substances: amlodipine, amlodipine losartan, losartan

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 Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study NCT01822639 · started 2013 · scored riskier than 1% of active trials completed
Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions NCT01797926 · started 2013 · scored riskier than 1% of active trials completed
Relative Bioavailability Study of One Amlodipine 10mg Tablet and One Rosuvastatin 20mg Tablet to Two Fixed Dose Combinations of Amlodipine (10mg) and Rosuvastatin (20mg) in Healthy Subjects Under Fasting Conditions NCT02075619 · started 2014 · scored riskier than 0% of active trials completed
A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323 NCT02094924 · started 2014 · scored riskier than 1% of active trials completed
To Investigate the Pharmacokinetics and Safety of Fluticasone Furoate (FF)/ Umeclidinium (UMEC) Combination Compared With FF and UMEC Monotherapies in Adult Healthy Volunteers Using a Dry Powder Inhaler (DPI) NCT01725685 · started 2012 · scored riskier than 2% 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.