Trial · NCT02697734
Outcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Randomized Participants With a Complete Response | at Week 12 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With mUFC ≤ ULN at Week 36 | At Week 36 | Full Analysis Set participants: comprises all randomized participants who received at least one dose of osilodrostat. Only a single arm is reported since the endpoint is 'To assess the complete response rate in both arms combined at Week 36 in patients receiving osilodrostat treatment.' | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in mUFC | Baseline, weeks 2,5,8,12,14,17,20,23,26,29,32,36,40,48,60,72,84,96 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | nmol/24hr | MEAN |
| SECONDARY | Time-to-first Control of mUFC - Number (%) of Participants With mUFC <=ULN | up to 12 weeks | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time-to-first Control of mUFC - Median Time to First Controlled mUFC Response | up to 12 weeks | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). | Days | MEDIAN |
| SECONDARY | Time-to-first Control of mUFC - % Event Probability Estimates | up to 12 weeks | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). | Percent (event probability estimates) | NUMBER |
| SECONDARY | Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN - Number (%) of Participants | up to 48 weeks | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN - Median Time to Escape From Normal mUFC | from week 26 to week 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). | days | MEDIAN |
| SECONDARY | Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN - % Event Probability Estimates | week 26 and week 36 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). | Percent (event probability estimates) | NUMBER |
| SECONDARY | Change From Baseline in Bone Mineral Density (BMD) by Dual-energy X-ray Absorptiometry (DXA) Scan at the Femoral Neck, Hip and Spinal Cord - QC Corrected | Baseline, week 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | g/cm2 | MEAN |
| SECONDARY | Change From Baseline in Bone Mineral Density (BMD) T-score by Dual-energy X-ray Absorptiometry (DXA) Scan at the Femoral Neck, Hip and Spinal Cord - QC Corrected | Baseline, week 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | scores on a scale | MEAN |
| SECONDARY | Patients With a Complete Response (mUFC ≤ ULN) or a Partial Response (mUFC Decrease ≥ 50% From Baseline and >ULN) at Week 12, 36 and 48 | baseline, week 12, 36 and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Fasting Plasma Glucose | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | mg/dL | MEAN |
| SECONDARY | Change in Hemoglobin A1C | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | percentage of Hemoglobin A1C | MEAN |
| SECONDARY | Change in Cholesterol | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | mmol/L | MEAN |
| SECONDARY | Change in LDL Cholesterol | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | mmol/L | MEAN |
| SECONDARY | Change in HDL Cholesterol | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | mmol/L | MEAN |
| SECONDARY | Change in Triglyceride | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | mmol/L | MEAN |
| SECONDARY | Change in Standing Systolic Blood Pressure | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | mmHg | MEAN |
| SECONDARY | Change in Supine Systolic Blood Pressure | Baseline, weeks 12, 36, and 48 | Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo). The number analyzed varied from one visit to another because of missed visits, missed assessments, early discontinuation from the study, and completion of the extension phase. | mmHg | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT02697734/outcomes