Trial · NCT03621280
Open-label Treatment in Cushing's Syndrome
NCT03621280, Phase 3, Completed, Cortendo AB; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Open-label Treatment in Cushing's Syndrome. Trials, record NCT03621280. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03621280
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Treatment in Cushing's Syndrome
- NCT number
- NCT03621280
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 51 participants, actual
- Lead sponsor
- Cortendo AB
- Conditions
- Cushing Syndrome, Cushing Disease
- Interventions
- Levoketoconazole
- First posted
- 2018-08-08
- Last updated
- 2025-06-19
- Results first posted
- 2025-06-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | From parent study Baseline to final study visit or up to a maximum of 3 years, whichever comes first. | Proportions of participants with mUFC: 1) Less or equal to the ULN of the reference range, 2) Above the ULN to 1.5x the ULN, and 3) Above 1.5x the ULN. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | From parent study Baseline to final study visit or up to a maximum of 3 years, whichever comes first. | The number of participants at each timepoint is based on both the number of participants with evaluable mUFC data at each timepoint and the number of participants remaining in the study at each assessment timepoint. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | Original Baseline / Less than or equal to ULN | 0 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | Original Baseline / Above ULN to 1.5x ULN | 1 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | Original Baseline / Above 1.5x ULN | 50 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | COR-2017-OLE Baseline / Less than or equal to ULN | 26 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | COR-2017-OLE Baseline / Above ULN to 1.5x ULN | 12 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | COR-2017-OLE Baseline / Above 1.5x ULN | 12 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | Month 6 / Less than or equal to ULN | 20 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | Month 6 / Above ULN to 1.5x ULN | 10 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | Month 6 / Above 1.5x ULN | 10 | Participants | |
| Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN) | All Participants | Month 12 / Less than or equal to ULN | 15 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levoketoconazole | 51 | |
| Overall Study | COMPLETED | Levoketoconazole | 24 | |
| Overall Study | NOT COMPLETED | Levoketoconazole | 27 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Corona virus infection | Infections and infestations | All Participants | 8 | 51 | 8 |
| other | Upper respiratory tract infection | Infections and infestations | All Participants | 5 | 51 | 8 |
| other | Urinary tract infection | Infections and infestations | All Participants | 3 | 51 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | All Participants | 3 | 51 | 3 |
| other | Palpitations | Cardiac disorders | All Participants | 3 | 51 | 4 |
| other | Vertigo | Ear and labyrinth disorders | All Participants | 5 | 51 | 5 |
| other | Adrenal insufficiency | Endocrine disorders | All Participants | 5 | 51 | 7 |
| other | Nausea | Gastrointestinal disorders | All Participants | 17 | 51 | 26 |
| other | Diarrhoea | Gastrointestinal disorders | All Participants | 7 | 51 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | All Participants | 3 | 51 | 3 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 3 | 51 |
| Total, other adverse events | All Participants | 48 | 51 |
| Total, serious adverse events | All Participants | 20 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03621280
GET https://conductscience.org/api/trials/v1/NCT03621280/results?page=2