Trial · NCT06430528
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase) | Through phase 1, approximately 24 weeks | based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy |
| Secondary | Correlation between AM cortisol and 11OHA4 measurements | Up to end of study, approximately 48 weeks | compare biomarkers measured by mass spectrometry. This may be calculated Upon 12 participants completing phase 1 or at the end of the study, whichever comes first. |
| Secondary | Rate of adrenal insufficient episodes per patient per year | Up to end of phase 2 (approximately 48 weeks) | based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy |
| Secondary | Frequency of cortisol withdrawal symptoms | Up to end of phase 2 (approximately 48 weeks) | Based on patient-reported outcomes |
| Secondary | Change in weight | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Change in diastolic blood pressure | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Change in systolic blood pressure | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Mean change in HgbA1c for participant with HgbA1c > 6.4% at entry. | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Change in number of concomitant medications | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic notes, total number of medications used to treat Cushing syndrome comorbidities |
| Secondary | Adrenal Insufficiency Assessment Questionnaire scores | Up to end of study, approximately 48 weeks | Custom questionnaire for adrenal insufficiency- 4 Likert questions with scores ranging from 4-20. Higher scores indicate worse symptoms. |
| Secondary | RAND Short Form (SF)-36 scores | Up to end of study, approximately 48 weeks | The 36-Item Short Form Health Survey (SF-36) is standard RAND form used clinically. It is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 with higher scores indicating a better Health-related Quality of Life. |
| Secondary | Ease of titration | Up to end of phase 1 (approximately 48 weeks) | Investigators' judgment (1-5 scale) |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06430528/registered