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NCT03697109 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
A Phase 3 study of Cushing Syndrome, sponsored by Corcept Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT03697109: Completed Phase 3 study of Cushing Syndrome, sponsored by Corcept Therapeutics.
NCT03697109 is a Phase 3 study of Cushing Syndrome that has completed, run by Corcept Therapeutics. The registered enrollment target is 152 participants, roughly in line with the 163-participant average among 9 other Cushing Syndrome trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03697109, a Phase 3 study of Cushing Syndrome, has completed, sponsored by Corcept Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).
Primary Outcome
Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Relacorilant
Study Locations (20)
New York
- Site 8 - Albany
- Site 6 - Jamaica
- Site 57 - New York
- Site 35 - New York
- Site 39 - New York
California
- Site 36 - Los Angeles
- Site 68 - Torrance
Arizona
- Site 21 - Phoenix
Florida
- Site 10 - Miami
Georgia
- Site 14 - Atlanta
Illinois
- Site 41 - Chicago
Indiana
- Site 7 - Indianapolis
Louisiana
- Site 2 - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2024-04-15 |
| Phase | Phase 3 |
What the finished NCT03697109 record still lists
NCT03697109 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 163-participant average among 9 other Cushing Syndrome trials with a reported enrollment target.
The record links to 1 condition, with Cushing Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03697109 names 20 study sites across 15 states, led by New York, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03697109 about?
NCT03697109 is a clinical study titled "A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome". This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hyper...
What is the current status of trial NCT03697109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2018-11-15. Estimated completion is 2024-04-15.
What conditions does trial NCT03697109 study?
This clinical trial studies the following conditions: Cushing Syndrome.
What interventions are being tested in trial NCT03697109?
The interventions under investigation include: Placebo (OTHER), Relacorilant (DRUG).
Who is sponsoring clinical trial NCT03697109?
This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03697109 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03697109's enrollment target sits among peer trials
152 3rd of 9 higher than 7 of 9 other Cushing Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cushing Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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