Trial · NCT01838551
Treatment for Endogenous Cushing's Syndrome
NCT01838551, Phase 3, Completed, Cortendo AB; results first posted 2021-04-19
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Treatment for Endogenous Cushing's Syndrome. Trials, record NCT01838551. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01838551
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment for Endogenous Cushing's Syndrome
- NCT number
- NCT01838551
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 94 participants, actual
- Lead sponsor
- Cortendo AB
- Conditions
- Endogenous Cushing's Syndrome
- Interventions
- Levoketoconazole
- First posted
- 2013-04-24
- Last updated
- 2021-04-19
- Results first posted
- 2021-04-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome. | 6 months of maintenance phase therapy without a prior dose increase during that phase | The response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The proportion of responders at the End of Maintenance Phase visit, following 6 months of treatment in the Maintenance Phase, for all dose groups combined was estimated using a generalized linear model with repeated measurements based on a binomial distribution with a logit link function and with region (US vs. non-US), concurrent CS medical conditions (diabetes \[Yes/No\], hypertension \[Yes/No\]), age (rounded median split based on the ITT population), sex, disease duration (years), prior CS medication (Yes/No), prior radiation therapy (Yes/No) as Baseline covariates and visit as an independent factor. The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented. |
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 | Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome. | 6 months of maintenance phase therapy without a prior dose increase during that phase | The primary efficacy analysis was based on the ITT population. Subjects were imputed as non-responders under any of the following conditions: withdrew anytime prior to the Month 6 of Maintenance phase; had a dose increase relative to the therapeutic dose during Maintenance phase; Month 6 mUFC data were missing or inadequate; or had received radiation therapy and exhibited no rebound increase in mUFC following withdrawal of levoketoconazole immediately after the end of Maintenance phase. | proportion of subjects meeting endpoint | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome. | Levoketoconazole All Doses | .30 | 95% Confidence Interval .21 to .40 | proportion of subjects meeting endpoint |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levoketoconazole All Doses | 94 | |
| Overall Study | COMPLETED | Levoketoconazole All Doses | 46 | |
| Overall Study | NOT COMPLETED | Levoketoconazole All Doses | 48 |
Source ClinicalTrials.gov
Adverse events65
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 | Palpitations | Cardiac disorders | Levoketoconazole All Doses | 7 | 94 | |
| other | Abdominal pain | Gastrointestinal disorders | Levoketoconazole All Doses | 7 | 94 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Levoketoconazole All Doses | 9 | 94 | |
| other | Diarrhea | Gastrointestinal disorders | Levoketoconazole All Doses | 14 | 94 | |
| other | Dyspepsia | Gastrointestinal disorders | Levoketoconazole All Doses | 5 | 94 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Levoketoconazole All Doses | 5 | 94 | |
| other | Nausea | Gastrointestinal disorders | Levoketoconazole All Doses | 31 | 94 | |
| other | Vomiting | Gastrointestinal disorders | Levoketoconazole All Doses | 10 | 94 | |
| other | Asthenia | General disorders | Levoketoconazole All Doses | 6 | 94 | |
| other | Edema peripheral | General disorders | Levoketoconazole All Doses | 18 | 94 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levoketoconazole All Doses | 1 | 94 |
| Total, other adverse events | Levoketoconazole All Doses | 92 | 94 |
| Total, serious adverse events | Levoketoconazole All Doses | 16 | 94 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01838551
GET https://conductscience.org/api/trials/v1/NCT01838551/events?page=2