Trial · NCT00434148
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
NCT00434148, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease. Trials, record NCT00434148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00434148
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
- NCT number
- NCT00434148
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 162 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cushing's Disease
- Interventions
- Pasireotide
- First posted
- 2007-02-12
- Last updated
- 2016-03-08
- Other registries' IDs
- eudract:2006-004111-22
- Results first posted
- 2013-02-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group | 6 months | The full analysis set (FAS) was the primary population for efficacy and consisted of all 162 randomized patients who received at least one dose of paseriotide. | Responders | NUMBER |
| SECONDARY | Change From Baseline in mUFC | baseline, 3 months, 12 months | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | nmol/24h | MEAN |
| SECONDARY | Time to First UFC Response | 12 months | Full Analysis Set (FAS): The full analysis set included all randomized participants who received at least one dose of study drug. | months | MEDIAN |
| 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 | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | Percent change | MEAN |
| 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 | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | percent change | MEAN |
| 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 | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | mmHg | MEAN |
| 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 | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | kg/m^2 | MEAN |
| 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 | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | cm | MEAN |
| 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 | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | mmol/L | MEAN |
| 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 | Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug. | score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group352
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group | Pasireotide 600 ug | 12 | 95% Confidence Interval 7.0 to 22.3 | Responders | |
| Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group | Pasireotide 900 ug | 21 | 95% Confidence Interval 16.6 to 35.9 | Responders | |
| Change From Baseline in mUFC | Pasireotide 600 ug | month 3 (n=61,62) | -375.8 | Standard Deviation 631.07 | nmol/24h |
| Change From Baseline in mUFC | Pasireotide 900 ug | month 3 (n=61,62) | -343.4 | Standard Deviation 485.48 | nmol/24h |
| Change From Baseline in mUFC | Pasireotide 600 ug | month 12 (n=37,35) | -572.6 | Standard Deviation 941.44 | nmol/24h |
| Change From Baseline in mUFC | Pasireotide 900 ug | month 12 (n=37,35) | -350.7 | Standard Deviation 380.25 | nmol/24h |
| Time to First UFC Response | Pasireotide 600 ug | 1.0 | Inter-Quartile Range 0.9 to 2.7 | months | |
| Time to First UFC Response | Pasireotide 900 ug | 1.0 | Inter-Quartile Range 0.9 to 2.7 | months | |
| Percent Change From Baseline in Serum Cortisol | Pasireotide 600 ug | month 0.5 (n=77,76) | -4.0 | Standard Deviation 28.23 | Percent change |
| Percent Change From Baseline in Serum Cortisol | Pasireotide 900 ug | month 0.5 (n=77,76) | -10.8 | Standard Deviation 30.57 | Percent change |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pasireotide 600 ug | 82 | |
| Overall Study | STARTED | Pasireotide 900 ug | 80 | |
| Overall Study | Completed Month 12 | Pasireotide 600 ug | 39 | |
| Overall Study | Completed Month 12 | Pasireotide 900 ug | 39 | |
| Overall Study | Completed m. 12; Did Not Enter Extension | Pasireotide 600 ug | 13 | |
| Overall Study | Completed m. 12; Did Not Enter Extension | Pasireotide 900 ug | 7 | |
| Overall Study | Completed Month 12; Entered Extension | Pasireotide 600 ug | 26 | |
| Overall Study | Completed Month 12; Entered Extension | Pasireotide 900 ug | 32 | |
| Overall Study | COMPLETED | Pasireotide 600 ug | 13 | |
| Overall Study | COMPLETED | Pasireotide 900 ug | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events272
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 | Pasireotide 600 ug | 1 | 82 | |
| other | Anaemia | Blood and lymphatic system disorders | Pasireotide 900 ug | 5 | 80 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Pasireotide 600 ug | 3 | 82 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Pasireotide 900 ug | 4 | 80 | |
| other | Sinus bradycardia | Cardiac disorders | Pasireotide 600 ug | 8 | 82 | |
| other | Sinus bradycardia | Cardiac disorders | Pasireotide 900 ug | 2 | 80 | |
| other | Vertigo | Ear and labyrinth disorders | Pasireotide 600 ug | 4 | 82 | |
| other | Vertigo | Ear and labyrinth disorders | Pasireotide 900 ug | 6 | 80 | |
| other | Hypothyroidism | Endocrine disorders | Pasireotide 600 ug | 3 | 82 | |
| other | Hypothyroidism | Endocrine disorders | Pasireotide 900 ug | 4 | 80 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pasireotide 600 ug | ||
| Total, all-cause mortality | Pasireotide 900 ug | ||
| Total, other adverse events | Pasireotide 600 ug | 78 | 82 |
| Total, other adverse events | Pasireotide 900 ug | 79 | 80 |
| Total, serious adverse events | Pasireotide 600 ug | 23 | 82 |
| Total, serious adverse events | Pasireotide 900 ug | 25 | 80 |
Source ClinicalTrials.gov
Papers6
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pasireotide 600 ug vs Pasireotide 900 ug: serious adverse events |
Source Trial comparisons
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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