Trial · NCT05579327
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of change from baseline in serum total T3 (ln-transformed) during the 30-day double-blind Randomized Treatment Period | Baseline to Day 30 | |
| Primary | Proportion of participants who meet the rescue criterion (serum total T3 > ULN) during the 30-day double-blind Randomized Treatment Period | Baseline to Day 30 | |
| Secondary | Change in serum thyroid hormone variables (T3, T4, TSH, fT3, and fT4) | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Heart rate | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Systolic blood pressure | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Rate pressure product (heart rate × systolic blood pressure) | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Heart rate Z scores | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Body weight | From i) Screening to End of Study (up to 26 weeks), ii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks). | |
| Secondary | Safety endpoints: Number of participants with treatment-emergent adverse events (TEAEs) | From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks). | |
| Secondary | Safety endpoints: Number of participants with TEAEs related to clinical laboratory tests | From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks). | Safety laboratory variables (full blood count, serum renal and liver biomarkers, total and low-density lipoprotein \[LDL\] cholesterol, and electrolytes). |
| Secondary | Safety endpoints: Number of participants with TEAEs related to vital signs variables | From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks). | Standard vital signs variables (heart rate, temperature, respiration rate, blood pressure, and body weight). |
| Secondary | Safety endpoints: 12-lead Electrocardiograms (ECGs): Number of clinically significant abnormal results (investigator interpretations) | At Screening, Day 1, and End of Study (up to 26 weeks). | |
| Secondary | Safety endpoints: Physical examinations: Number of clinically significant abnormal results | From i) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks), ii) Baseline to Follow-up (up to 10 weeks) | Body systems include cardiovascular system, general appearance, gastrointestinal system, head/eyes/ears/nose/throat, musculoskeletal system, and nervous system. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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