Trial · NCT00434148
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group | 6 months | A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6. |
| Secondary | Change From Baseline in mUFC | baseline, 3 months, 12 months | Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement. |
| Secondary | Time to First UFC Response | 12 months | Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response. |
| Secondary | Percent Change From Baseline in Serum Cortisol | baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months | Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement. |
| Secondary | Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH) | baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months | Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP) | baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60 | Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI) | baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference | baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60 | Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides | baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60 | Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score | baseline, month 3, month 6, month 12, month 18, month 24 | The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score | baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60 | The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score \>= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD) | baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60 | BMD was measured using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L1-L4), proximal femur (total hip) and proximal femur (femur neck). A negative change from baseline indicates imrpovement. |
| Secondary | Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition | baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60 | Body composition as in percentage of body fat by region was assessed by total body scan. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Tumor Volume | baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 months | Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement. |
| Secondary | Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score | baseline, 3 months, 6 months, 12 months | A Cushing's syndrome health related quality of life (HRQL) questionnaire was completed. The Cushing's Syndrome HRQL questionnaire contains 12 sentences with 5 possible answers each. The answers are based on Likert scales, with 5 response categories: Always, Often, Sometimes, Rarely and Never; or Very much, Quite a bit, Somewhat, Very little, and Not at all. The answers to each of the items are rated on a scale of 1 to 5. "1" corresponds to the response category "Always" or "Very much" and "5" corresponds to the category "Never" or "Not at all". The score is the sum of all item responses and can range from 12 to 60 points. The lower the score, the greater the Cushing's Syndrome impacts on HRQoL. A positive change from baseline indicates improvement. |
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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