Trial · NCT03697109
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | 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 antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason. |
| Primary | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase | |
| Secondary | Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase | Before and at time intervals up to 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | |
| Secondary | Change in Hemoglobin HbA1c During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | |
| Secondary | Change in 2-hour Plasma Glucose During the RW Phase | Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT). |
| Secondary | Change in SBP and DBP During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | Blood pressure was measured by 24-hour ABPM. |
| Secondary | Change in Body Weight During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | |
| Secondary | Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) | |
| Other | Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns. |
| Other | Percent Change in Tissue Fat Mass During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | Tissue fat mass was measured by dual energy X-ray absorptiometry (DXA) scan. Reported are change in in absolute tissue fat mass and change in percent tissue fat mass. |
| Other | Number of Patients Who Worsened, as Assessed by the Global Clinical Response, During the RW Phase | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) | The Global Clinical Response assessment measures the patient's signs and symptoms of endogenous hypercortisolism in 7 clinical categories: 1) glucose parameters, 2) blood pressure parameters, 3) body composition parameters, 4) clinical appearance, 5) strength parameters, 6) psychiatric health/cognitive function parameters, and 7) quality of life using the Cushing QoL score. The overall response based on the totality of signs and symptoms is rated as +1 for improved, 0 for unchanged, and -1 for worsened. Each patient's final score is the median of ratings given by 3 members of the Data Review Board. |
| Other | Change in Percent Tissue Fat Mass During the OL Phase | Baseline and Week 22 (end of OL Phase) | Tissue fat mass was measured by DXA scan. |
| Other | Change in Cushing QoL Normalized Total Score During the OL Phase | Baseline and Week 22 (end of OL Phase) | The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns. |
| Other | Change in Beck Depression Inventory-II (BDI-II) Score During the OL Phase | Baseline and Week 22 (end of OL Phase) | The BDI-II is a 21-question self-report inventory that measures depression. Each answer is scored with values of 0 to 3. The total score ranges from 0 to 63. Scores of 0 to 13 indicate minimal depression, 14 to 19; mild depression; 20 to 28; moderate depression; 29 to 63; severe depression. |
| Other | Mean Change From Baseline in Body Weight During the OL Phase | Baseline and Week 22 (end of OL Phase) | |
| Other | Change in 2-hour Plasma Glucose During the OL Phase | Baseline and Week 22 (end of OL Phase) | Plasma glucose was measured using the 2-hour oGTT. |
| Other | Change in Hemoglobin HbA1c During the OL Phase | Baseline and Week 22 (end of OL Phase) | |
| Other | Change in SBP and DBP During the OL Phase | Baseline and Week 22 (end of OL Phase) | Blood pressure was measured by 24-hour ABPM. |
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.
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