Trial · NCT03606408
Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699
NCT03606408, Phase 2, Completed, RECORDATI GROUP; results first posted 2024-12-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699. Trials, record NCT03606408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03606408
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699
- NCT number
- NCT03606408
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 127 participants, actual
- Lead sponsor
- RECORDATI GROUP
- Conditions
- Cushing's Syndrome
- Interventions
- osilodrostat
- First posted
- 2018-07-30
- Last updated
- 2024-12-18
- Results first posted
- 2024-12-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse/Serious Adverse Events | up to 5 years | To evaluate long-term safety data with osilodrostat treatment (Frequency and severity of adverse events (AEs)/serious adverse events (SAEs)) |
| Secondary | Percentage of Patients With Clinical Benefit | up to of 5 years | Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits based on medical check-up and lab values such as Urine Free Cortisol. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse/Serious Adverse Events | up to 5 years | The starting dose of this roll-over study was the same as the one the patients were taking at the end of the parent studies. In addition, they underwent to dose adjustment according to the urine cortisol level and possible AEs. The daily dosage ranged from 1mg every 3 days to 30mg twice a day. So, the results are not reported according to the drug dosage and data has been analysed as one arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With Clinical Benefit | up to of 5 years | The starting dose of this roll-over study was the same as the one the patients were taking at the end of the parent studies. In addition, they underwent to dose adjustment according to the urine cortisol level and possible AEs. The daily dosage ranged from 1mg every 3 days to 30mg twice a day. So it is not feasible to report the results according to the drug dosage and data has been analysed as one arm. | 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 |
|---|---|---|---|---|---|
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Adverse events (AEs) | 115 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Treatment-related AEs | 50 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Adverse events of CTCAE Grade ≥ 3 | 34 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Treatment-related AEs of CTCAE Grade ≥ 3 | 3 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Serious adverse events | 35 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Treatment-related SAEs | 4 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Fatal SAEs | 2 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Treatment-related fatal SAEs | 0 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Adverse events leading to discontinuation | 14 | Participants | |
| Number of Participants With Adverse/Serious Adverse Events | Osilodrostat | Treatment-related AEs leading to discontinuation | 5 | 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 | Osilodrostat | 127 | |
| Overall Study | COMPLETED | Osilodrostat | 99 | |
| Overall Study | NOT COMPLETED | Osilodrostat | 28 |
Source ClinicalTrials.gov
Adverse events61
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 | Hypertension | Vascular disorders | Osilodrostat | 11 | 127 | |
| other | COVID-19 | Infections and infestations | Osilodrostat | 29 | 127 | |
| other | Abdominal pain | Gastrointestinal disorders | Osilodrostat | 9 | 127 | |
| other | Adrenal insufficiency | Endocrine disorders | Osilodrostat | 16 | 127 | |
| other | Vomiting | Gastrointestinal disorders | Osilodrostat | 9 | 127 | |
| other | Nausea | Gastrointestinal disorders | Osilodrostat | 14 | 127 | |
| other | Diarrhoea | Gastrointestinal disorders | Osilodrostat | 13 | 127 | |
| other | Asthenia | General disorders | Osilodrostat | 9 | 127 | |
| other | Fatigue | General disorders | Osilodrostat | 9 | 127 | |
| other | Pyrexia | General disorders | Osilodrostat | 8 | 127 |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Osilodrostat | 2 | 127 |
| Total, other adverse events | Osilodrostat | 115 | 127 |
| Total, serious adverse events | Osilodrostat | 35 | 127 |
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.
Data dates
The day each source was copied for this release.
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 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/NCT03606408
GET https://conductscience.org/api/trials/v1/NCT03606408/results?page=2