Comparison · NCT03277690-fb3303c9
Levoketoconazole vs Placebo: Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Levoketoconazole vs Placebo: Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole. Trial comparisons, record NCT03277690-fb3303c9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03277690-fb3303c9
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.409 | 0.233 | 0.613 | wilson | |
| Risk in group 2 | 0.955 | 0.782 | 0.992 | wilson | |
| Risk difference, group 1 minus group 2 | -0.545 | -0.726 | -0.279 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.429 | 0.257 | 0.714 | log | |
| Odds ratio, group 1 over group 2 | 0.033 | 0.00373 | 0.291 | log | |
| Number needed to treat, for one fewer participant with the outcome on Levoketoconazole than on Placebo | 1.83 | 1.38 | 3.59 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Levoketoconazole | Double blind withdrawal phase: Levoketoconazole (up to a dose of 1200 mg); Double blind restoration phase: Levoketoconazole plus Placebo~Levoketoconazole: During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily.~During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo. | 9 | 22 | OG000 |
| Group 2 | Placebo | Double blind withdrawal phase: Placebo; Double blind restoration phase: Placebo plus Levoketoconazole~Placebo: During the double-blind Withdrawal Phase, patients will receive placebo tablets.~During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole. | 21 | 22 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.
- Description
Urinary free cortisol (UFC) level measurement: Loss of therapeutic response is inferred based on mUFC from three 24-hour UFC measurements obtained at any visit from second through final Randomized Withdrawal Phase visits (RW1 through RW5 inclusive) when: (1) mUFC is above 1.5X the ULN of the central laboratory's reference range, OR (2) mUFC is more than 40% above the baseline (RW0) value, if the RW0 value is above the ULN (i.e. \>1.0X ULN)1, OR (3) an early rescue criterion is met.
- Time frame
- max. 9.5 weeks
- Population
- Intent to Treat (ITT)
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.
- NCT number
- NCT03277690
- Phases
- PHASE3
- Conditions
- Endogenous Cushing's Syndrome
- Interventions
- Levoketoconazole, Placebo
- Lead sponsor
- Cortendo AB
- Results first posted
- 2022-11-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03277690?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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