Trial · NCT01374906
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration | Month 7 | Percentage of participants that attained a mean urinary free cortisol (mUFC) \<= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value. |
| Secondary | Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4 | Month 7 | Percentage of participants that attain a mUFC ≤ 1.0×ULN at Month 7 and had not had a dose increase at Month 4. Patients who had a dose increase prior to Month 7 were counted as non-responders in this analysis. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value. A responder was defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4. |
| Secondary | Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | baseline, Month 7 (M7), Month 12 (M12), Month 24 (M24) , Month 36 (M36) | Actual change in mUFC (nmol/24h) from baseline by randomized groups. |
| Secondary | Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline | M7, M12, M24, M36 | Percentage change in mUFC (nmol/24h) from baseline by randomized groups. |
| Secondary | Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN | M7, M12, M24, M36 | Controlled responder: mUFC ≤ 1.0×ULN by randomized groups. |
| Secondary | Percentage of Patients Who Attain mUFC ≤1.0 x ULN or Have at Least 50 % Reduction From Baseline in mUFC | M7, M12, M24, M36 | Controlled responder: mUFC ≤ 1.0×ULN. Partially controlled responder: at least 50% reduction in mUFC from Baseline, and mUFC \>1.0×ULN. |
| Secondary | Percentage of Patients Who Are Controlled Responders (mUFC ≤ 1.0 xULN) on at Least 4 of the 7 mUFC Assessments by Month 7 & on at Least 7 of the 12 mUFC Assessments by Month 12. | Month 7, Month 12 | Percentage of patients with mUFC ≤ 1.0 x ULN at a minimum of 4 months up to and including Month 7, and at a minimum of 7 months up to and including Month 12 by randomized groups. |
| Secondary | Percentage of Patients With Uncontrolled Response at Month 7 & Month 12 Within the Subset of Patients Who Had Uncontrolled Response at a) Months 1 and 2; b) Months 1, 2, and 3 | Month 7, Month12 | Percentage of patients with mUFC \> 1.0 xULN at Month 7 and Month 12 within the subset of patients who were uncontrolled at a) Months 1 \& 2, b) Months 1, 2, \& 3 by randomized groups. |
| Secondary | Percent of Participants Attaining a mUFC ≤ 1.0 x ULN or at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points | Momth 7, Month 12 | Time to first achievement of attaining a mUFC ≤ 1.0 x ULN or at least a 50% reduction in mUFC from baseline by randomized groups. |
| Secondary | Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points | Month 6, 12, 18 | Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC \>1.0 x ULN and the reduction from baseline falls to less than 50% for the first time. |
| Secondary | Percentage Change From Baseline on Plasma Adrenocorticotropic Hormone (ACTH) Over Time | Months 7, 12, 24 & 36 | Percentage change in ACTH (pmol/L) from Baseline by randomized groups. |
| Secondary | Percentage Change From Baseline on Serum Cortisol Over Time | Months 7, 12, 24 & 36 | Percentage change in serum cortisol (nmol/L) from Baseline by randomized groups. |
| Secondary | Actual Change From Baseline in Clinical Signs Over Time: Blood Pressure | Month 7 | Change in blood pressure measurements from Baseline |
| Secondary | Actual Change From Baseline in Clinical Signs Over Time: Body Mass Index (BMI) | Month 7 | Change in BMI measurements from Baseline |
| Secondary | Actual Change From Baseline in Clinical Signs Over Time: Weight | Month 7 | Change in weight measurements from Baseline |
| Secondary | Actual Change From Baseline in Clinical Signs Over Time: Body Composition: Region | Month 7 | Change in body composition: region measurements from Baseline |
| Secondary | Actual Change From Baseline in Clinical Signs Over Time: Waist Circumference | Month 7 | Change in waist circumference measurements from Baseline |
| Secondary | Actual Change From Baseline in Clinical Signs Over Time: Cholesterol & Triglycerides | Month 7 | Change in parameter measurements: cholesterol \& triglycerides from Baseline |
| Secondary | Percentage Change From Baseline in Clinical Signs Over Time | Month 7 | Percentage change in parameter measurements: blood pressure, body mass index, waist circumference, fasting serum lipid profile, weight, bone density and body composition (examined by DXA scan) from Baseline |
| Secondary | Percentage of Participants Having a Favorable Shift From Baseline in Clinical Signs | Month 7 | This includes patients with improvements in symptoms from baseline. Clinical signs over time include: facial rubor, fat pads, hirsutism, striae, (via photographs by a second local physician who was blinded to the treatment dose and time point of the photograph) and muscle strength. |
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
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