Trial · NCT02804750
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
NCT02804750, Phase 2, Completed, Corcept Therapeutics; results first posted 2019-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate CORT125134 in Participants With Cushing's Syndrome. Trials, record NCT02804750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02804750
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
- NCT number
- NCT02804750
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Corcept Therapeutics
- Conditions
- Cushing's Syndrome
- Interventions
- CORT125134
- First posted
- 2016-06-17
- Last updated
- 2019-10-15
- Results first posted
- 2019-09-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With One or More Adverse Events | Group 1: up to Week 16; Group 2: up to Week 20 | All treatment-emergent adverse events were recorded and summarized. |
| Primary | Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events | Group 1: up to Week 16; Group 2: up to Week 20 | All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized. |
| Secondary | Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134 | Group 1: Week 12 or last observation; Group 2: Week 16 or last observation | Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication. |
| Secondary | Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134 | Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2) | Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With One or More Adverse Events | Group 1: up to Week 16; Group 2: up to Week 20 | All enrolled participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events | Group 1: up to Week 16; Group 2: up to Week 20 | All enrolled participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134 | Group 1: Week 12 or last observation; Group 2: Week 16 or last observation | All enrolled participants with hypertension at Baseline who received at least one dose of study drug and had at least one post-baseline assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134 | Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2) | All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had at least one post-baseline assessment. | Percentage of participants | NUMBER |
| POST_HOC | Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109 | Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2) | All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had non-missing post-baseline data collected, with exclusions based on clinical judgment and/or important protocol deviations applied on a visit and outcome level rather than a participant level. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With One or More Adverse Events | Group 1: Low-dose Group | 15 | Participants | ||
| Percentage of Participants With One or More Adverse Events | Group 2: High-dose Group | 18 | Participants | ||
| Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events | Group 1: Low-dose Group | 3 | Participants | ||
| Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events | Group 2: High-dose Group | 7 | Participants | ||
| Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134 | Group 1: Low-dose Group | 41.67 | 95% Confidence Interval 15.17 to 72.33 | Percentage of participants | |
| Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134 | Group 2: High-dose Group | 63.64 | 95% Confidence Interval 30.79 to 89.07 | Percentage of participants | |
| Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134 | Group 1: Low-dose Group | 23.08 | 95% Confidence Interval 5.04 to 53.81 | Percentage of participants | |
| Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134 | Group 2: High-dose Group | 0 | 95% Confidence Interval 0 to 23.16 | Percentage of participants | |
Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109 | Group 1: Low-dose Group | 15.38 | 95% Confidence Interval 1.92 to 45.45 | Percentage of participants | |
Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109 | Group 2: High-dose Group | 50.00 | 95% Confidence Interval 21.09 to 78.91 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Group 1: Low-dose Group | 17 | |
| Period 1 | STARTED | Group 2: High-dose Group | 18 | |
| Period 1 | COMPLETED | Group 1: Low-dose Group | 17 | |
| Period 1 | COMPLETED | Group 2: High-dose Group | 15 | |
| Period 1 | NOT COMPLETED | Group 1: Low-dose Group | 0 | |
| Period 1 | NOT COMPLETED | Group 2: High-dose Group | 3 | |
| Period 2 | STARTED | Group 1: Low-dose Group | 17 | |
| Period 2 | STARTED | Group 2: High-dose Group | 15 | |
| Period 2 | COMPLETED | Group 1: Low-dose Group | 16 | |
| Period 2 | COMPLETED | Group 2: High-dose Group | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events234
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 | Diarrhoea | Gastrointestinal disorders | Group 1: Low-dose Group | 4 | 17 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: High-dose Group | 3 | 18 | |
| other | Nausea | Gastrointestinal disorders | Group 1: Low-dose Group | 3 | 17 | |
| other | Nausea | Gastrointestinal disorders | Group 2: High-dose Group | 5 | 18 | |
| other | Vomiting | Gastrointestinal disorders | Group 1: Low-dose Group | 2 | 17 | |
| other | Vomiting | Gastrointestinal disorders | Group 2: High-dose Group | 1 | 18 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Group 1: Low-dose Group | 1 | 17 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Group 2: High-dose Group | 2 | 18 | |
| other | Constipation | Gastrointestinal disorders | Group 1: Low-dose Group | 1 | 17 | |
| other | Constipation | Gastrointestinal disorders | Group 2: High-dose Group | 1 | 18 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Low-dose Group | 0 | 17 |
| Total, all-cause mortality | Group 2: High-dose Group | 0 | 18 |
| Total, other adverse events | Group 1: Low-dose Group | 15 | 17 |
| Total, other adverse events | Group 2: High-dose Group | 18 | 18 |
| Total, serious adverse events | Group 1: Low-dose Group | 0 | 17 |
| Total, serious adverse events | Group 2: High-dose Group | 4 | 18 |
Source ClinicalTrials.gov
Papers2
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Low-dose Group vs Group 2: High-dose Group: deaths from any cause | Trial comparisons |
| Group 1: Low-dose Group vs Group 2: High-dose Group: Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events | Trial comparisons |
| Group 1: Low-dose Group vs Group 2: High-dose Group: Percentage of Participants With One or More Adverse Events | Trial comparisons |
| Group 1: Low-dose Group vs Group 2: High-dose Group: serious adverse events | Trial comparisons |
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/NCT02804750
GET https://conductscience.org/api/trials/v1/NCT02804750/flow?page=2