Trial · NCT01374906
Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease
NCT01374906, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease. Trials, record NCT01374906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01374906
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease
- NCT number
- NCT01374906
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cushing's Disease
- Interventions
- pasireotide LAR, SOM230 LAR 30 mg, SOM230 LAR 10 mg
- First posted
- 2011-06-16
- Last updated
- 2018-05-22
- Other registries' IDs
- eudract:2009-011128-70
- Results first posted
- 2018-04-11
- Limitations and caveats
All analyses in this study were descriptive in nature. No comparisons were made between the two arms, and no p-values are reported. For the primary and key-secondary, success was based on estimating the response rate (and 95% CI) in each arm.
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration | Month 7 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| 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 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | baseline, Month 7 (M7), Month 12 (M12), Month 24 (M24) , Month 36 (M36) | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | nmol/24h | MEAN |
| SECONDARY | Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline | M7, M12, M24, M36 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | percentage change | MEAN |
| SECONDARY | Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN | M7, M12, M24, M36 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| 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 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| 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 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| 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 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| 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 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points | Month 6, 12, 18 | Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug. | Percentage of participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group218
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration | 10 mg Pasireotide LAR Dose | 41.9 | 95% Confidence Interval 30.51 to 53.94 | percentage of participants | |
| Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration | 30 mg Pasireotide LAR Dose | 40.8 | 95% Confidence Interval 29.65 to 52.67 | percentage of participants | |
| Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4 | 10 mg Pasireotide LAR Dose | 28.4 | 95% Confidence Interval 18.50 to 40.05 | percentage of participants | |
| Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4 | 30 mg Pasireotide LAR Dose | 31.6 | 95% Confidence Interval 21.39 to 43.25 | percentage of participants | |
| Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | 10 mg Pasireotide LAR Dose | M7 | -192.4 | Standard Deviation 271.59 | nmol/24h |
| Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | 30 mg Pasireotide LAR Dose | M7 | -234.3 | Standard Deviation 362.86 | nmol/24h |
| Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | 10 mg Pasireotide LAR Dose | M12 | -195.1 | Standard Deviation 282.46 | nmol/24h |
| Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | 30 mg Pasireotide LAR Dose | M12 | -247.6 | Standard Deviation 387.05 | nmol/24h |
| Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | 10 mg Pasireotide LAR Dose | M24 | -236.2 | Standard Deviation 292.91 | nmol/24h |
| Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline | 30 mg Pasireotide LAR Dose | M24 | -265.2 | Standard Deviation 313.47 | nmol/24h |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mg Pasireotide LAR Dose | 74 | |
| Overall Study | STARTED | 30 mg Pasireotide LAR Dose | 76 | |
| Overall Study | DC Dur Core Phs at/Prior to Data Cutoff | 10 mg Pasireotide LAR Dose | 24 | |
| Overall Study | DC Dur Core Phs at/Prior to Data Cutoff | 30 mg Pasireotide LAR Dose | 22 | |
| Overall Study | Completed Core Phase | 10 mg Pasireotide LAR Dose | 50 | |
| Overall Study | Completed Core Phase | 30 mg Pasireotide LAR Dose | 54 | |
| Overall Study | Completed Core/Did Not Enter Ext. Phase | 10 mg Pasireotide LAR Dose | 10 | |
| Overall Study | Completed Core/Did Not Enter Ext. Phase | 30 mg Pasireotide LAR Dose | 13 | |
| Overall Study | Completed Core Phase/Entered Ext. Phase | 10 mg Pasireotide LAR Dose | 40 | |
| Overall Study | Completed Core Phase/Entered Ext. Phase | 30 mg Pasireotide LAR Dose | 41 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events354
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 | Anaemia | Blood and lymphatic system disorders | 10 mg Pasireotide LAR Dose | 4 | 74 | |
| other | Anaemia | Blood and lymphatic system disorders | 30 mg Pasireotide LAR Dose | 5 | 76 | |
| other | Anaemia | Blood and lymphatic system disorders | All Patients | 9 | 150 | |
| other | Palpitations | Cardiac disorders | 10 mg Pasireotide LAR Dose | 4 | 74 | |
| other | Palpitations | Cardiac disorders | 30 mg Pasireotide LAR Dose | 3 | 76 | |
| other | Palpitations | Cardiac disorders | All Patients | 7 | 150 | |
| other | Sinus bradycardia | Cardiac disorders | 10 mg Pasireotide LAR Dose | 4 | 74 | |
| other | Sinus bradycardia | Cardiac disorders | 30 mg Pasireotide LAR Dose | 5 | 76 | |
| other | Sinus bradycardia | Cardiac disorders | All Patients | 9 | 150 | |
| other | Vertigo | Ear and labyrinth disorders | 10 mg Pasireotide LAR Dose | 5 | 74 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10 mg Pasireotide LAR Dose | ||
| Total, all-cause mortality | 30 mg Pasireotide LAR Dose | ||
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | 10 mg Pasireotide LAR Dose | 73 | 74 |
| Total, other adverse events | 30 mg Pasireotide LAR Dose | 76 | 76 |
| Total, other adverse events | All Patients | 149 | 150 |
| Total, serious adverse events | 10 mg Pasireotide LAR Dose | 22 | 74 |
| Total, serious adverse events | 30 mg Pasireotide LAR Dose | 19 | 76 |
| Total, serious adverse events | All Patients | 41 | 150 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01374906
GET https://conductscience.org/api/trials/v1/NCT01374906/registered?page=2