Trial · NCT01582061
An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.
NCT01582061, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. Trials, record NCT01582061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01582061
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.
- NCT number
- NCT01582061
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 104 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cushing's Disease
- Interventions
- Pasireotide sub-cutaneous
- First posted
- 2012-04-20
- Last updated
- 2018-06-19
- Results first posted
- 2018-06-19
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | Baseline up to approximately 256 weeks | Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade. |
| Secondary | Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) | Baseline, week 12, 24 and 48 | The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory. |
| Secondary | Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline | Baseline, week 12, 24 and 48 | The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory. |
| Secondary | Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores | Baseline, week 12, 24 and 48 | A 12-item Cushing's syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient • Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with 'Sometimes' or 'Somewhat', X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, 'change from baseline in WPAI-GH scores' are not included. |
| Secondary | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) | Baseline, week 12, 24 and 48 | Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments. |
| Secondary | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse | Baseline, week 12, 24 and 48 | Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100 |
| Secondary | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature | Baseline week 12, 24 and 48 | degrees celius |
| Secondary | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI) | Baseline, week 12, 24 and 48 | Percent change in patients reducing by at least one class level. Class levels: \<25.0, 25.0 to \<30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100 |
| Secondary | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight | Baseline, week 12, 24 and 48 | Clinically relevant threshold (at any time point) was reduction of ≥ 5% |
| Secondary | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength | Baseline, week 12, 24 and 48 | Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | Baseline up to approximately 256 weeks | Three additional arms were created to display subset of subjects with specific criteria. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) | Baseline, week 12, 24 and 48 | LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline | Baseline, week 12, 24 and 48 | LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method | percentage of participants | NUMBER |
| SECONDARY | Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores | Baseline, week 12, 24 and 48 | Only patients who completed at least 9 questions on questionnaire were included for that visit. | percent change in score | MEAN |
| SECONDARY | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) | Baseline, week 12, 24 and 48 | Number of patients with available data differed at visits | percent change of mmhg | MEAN |
| SECONDARY | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse | Baseline, week 12, 24 and 48 | Number of patients with available data differed at visits | percent change in bpm | MEAN |
| SECONDARY | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature | Baseline week 12, 24 and 48 | Number of patients with available data differed at visits | percent change in celius | MEAN |
| SECONDARY | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI) | Baseline, week 12, 24 and 48 | Number of patients with available data differed at visits | percent change in kg/m2 | MEAN |
| SECONDARY | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight | Baseline, week 12, 24 and 48 | Number of patients with available data differed at visits | percent change in kg | MEAN |
| SECONDARY | Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength | Baseline, week 12, 24 and 48 | Number of patients with available data differed at visits | percent change in scores | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group240
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 600 µg Bid - All Grades | Any primary system organ class | 53.1 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 600 μg - Grades 3/4 | Any primary system organ class | 53.1 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 900 μg - All Grades | Any primary system organ class | 29.1 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 900 μg - Grades 3/4 | Any primary system organ class | 27.3 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | All Patients - All Grades | Any primary system organ class | 40.4 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | All Patients - Grades 3/4 | Any primary system organ class | 39.4 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 600 µg Bid - All Grades | Metabolism and nutrition disorders | 26.5 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 600 μg - Grades 3/4 | Metabolism and nutrition disorders | 26.5 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 900 μg - All Grades | Metabolism and nutrition disorders | 12.7 | percentage of participants | |
| Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) | 900 μg - Grades 3/4 | Metabolism and nutrition disorders | 10.9 | percentage of participants |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pasireotide 600 μg | 49 | |
| Overall Study | STARTED | Pasireotide 900 μg | 55 | |
| Overall Study | COMPLETED | Pasireotide 600 μg | 21 | |
| Overall Study | COMPLETED | Pasireotide 900 μg | 19 | |
| Overall Study | NOT COMPLETED | Pasireotide 600 μg | 28 | |
| Overall Study | NOT COMPLETED | Pasireotide 900 μg | 36 |
Source ClinicalTrials.gov
Adverse events303
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | 600 µg Bid | 2 | 49 | |
| other | Bradycardia | Cardiac disorders | 900 µg Bid | 3 | 55 | |
| other | Bradycardia | Cardiac disorders | All Patients | 5 | 104 | |
| other | Sinus bradycardia | Cardiac disorders | 600 µg Bid | 4 | 49 | |
| other | Sinus bradycardia | Cardiac disorders | 900 µg Bid | 1 | 55 | |
| other | Sinus bradycardia | Cardiac disorders | All Patients | 5 | 104 | |
| other | Adrenal insufficiency | Endocrine disorders | 600 µg Bid | 4 | 49 | |
| other | Adrenal insufficiency | Endocrine disorders | 900 µg Bid | 1 | 55 | |
| other | Adrenal insufficiency | Endocrine disorders | All Patients | 5 | 104 | |
| other | Hypothyroidism | Endocrine disorders | 600 µg Bid | 3 | 49 |
1 to 10 of 303Source ClinicalTrials.gov
See all 303 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 600 µg Bid | 0 | 49 |
| Total, all-cause mortality | 900 µg Bid | 1 | 55 |
| Total, all-cause mortality | All Patients | 1 | 104 |
| Total, other adverse events | 600 µg Bid | 49 | 49 |
| Total, other adverse events | 900 µg Bid | 54 | 55 |
| Total, other adverse events | All Patients | 103 | 104 |
| Total, serious adverse events | 600 µg Bid | 13 | 49 |
| Total, serious adverse events | 900 µg Bid | 17 | 55 |
| Total, serious adverse events | All Patients | 30 | 104 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31379734 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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