Trial · NCT01137682
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
NCT01137682, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly. Trials, record NCT01137682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01137682
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
- NCT number
- NCT01137682
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 198 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acromegaly
- Interventions
- Pasireotide, octreotide LAR 30mg, lanreotide ATG 120mg
- First posted
- 2010-06-04
- Last updated
- 2018-04-05
- Other registries' IDs
- eudract:2009-016722-13
- Results first posted
- 2015-01-21
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | At 24 weeks | The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels \<2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to \< 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks. |
| Secondary | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 2.5 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (extension full analysis set) |
| Secondary | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Extension baseline up to approximately week 268 | The percentage of patients achieving normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set) |
| Secondary | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 2.5 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set) |
| Secondary | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set |
| Secondary | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set) |
| Secondary | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE baseline up to approximately 24 weeks | |
| Secondary | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE and extension baseline up to approximately 268 weeks | Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. |
| Secondary | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE baseline up to approximately 24 weeks | Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range |
| Secondary | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE and extension baseline up to approximately 268 weeks | Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range |
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 | Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | At 24 weeks | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Extension baseline up to approximately week 268 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | Participants | NUMBER | |
| SECONDARY | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | percentage of participants | NUMBER | |
| SECONDARY | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE baseline up to approximately 24 weeks | Number analyzed is based on available data at specific visits | mcg/L | MEAN |
| SECONDARY | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE and extension baseline up to approximately 268 weeks | Available data for analysis differed from visit to visit | mcg/L | MEAN |
| SECONDARY | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE baseline up to approximately 24 weeks | Available data for analysis varies from visit to visit | mcg/L | MEAN |
| SECONDARY | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE and extension baseline up to approximately 268 weeks | Available data for analysis differed from visit to visit | mcg/L | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group563
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | Pasireotide LAR 40 mg | 15.4 | 95% Confidence Interval 7.63 to 26.48 | percentage of participants | |
| Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | Pasireotide LAR 60 mg | 20.0 | 95% Confidence Interval 11.10 to 31.77 | percentage of participants | |
| Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | Control Arm (Octreotide or Lanreotide) | 0 | 95% Confidence Interval 0 to 5.28 | percentage of participants | |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Pasireotide LAR 40 mg Extension | Week 16 | 19.3 | 95% Confidence Interval 10.05 to 31.91 | percentage of participants |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Pasireotide LAR 60 mg Extension | Week 16 | 25.9 | 95% Confidence Interval 14.96 to 39.65 | percentage of participants |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Cross Over to Pasireotide Extension | Week 16 | 19.4 | 95% Confidence Interval 10.42 to 31.37 | percentage of participants |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Pasireotide LAR 40 mg Extension | Week 28 | 17.5 | 95% Confidence Interval 8.75 to 29.91 | percentage of participants |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Pasireotide LAR 60 mg Extension | Week 28 | 25.9 | 95% Confidence Interval 14.96 to 39.65 | percentage of participants |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Cross Over to Pasireotide Extension | Week 28 | 19.4 | 95% Confidence Interval 10.42 to 31.37 | percentage of participants |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Pasireotide LAR 40 mg Extension | Week 40 | 21.1 | 95% Confidence Interval 11.38 to 33.89 | percentage of participants |
1 to 10 of 563Source ClinicalTrials.gov
See all 563 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pasireotide LAR 40 mg | 65 | |
| Overall Study | STARTED | Pasireotide LAR 60 mg | 65 | |
| Overall Study | STARTED | Control Arm (Octreotide or Lanreotide) | 68 | |
| Overall Study | Not Treated | Pasireotide LAR 40 mg | 2 | |
| Overall Study | Not Treated | Pasireotide LAR 60 mg | 2 | |
| Overall Study | Not Treated | Control Arm (Octreotide or Lanreotide) | 1 | |
| Overall Study | Treated | Pasireotide LAR 40 mg | 63 | |
| Overall Study | Treated | Pasireotide LAR 60 mg | 63 | |
| Overall Study | Treated | Control Arm (Octreotide or Lanreotide) | 67 | |
| Overall Study | Completed 24-Week Core Phase | Pasireotide LAR 40 mg | 59 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events378
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 LAR 40 mg | 9 | 63 | |
| other | Anaemia | Blood and lymphatic system disorders | Pasireotide LAR 60 mg | 10 | 62 | |
| other | Anaemia | Blood and lymphatic system disorders | Cross-over to Pasireotide | 16 | 62 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pasireotide LAR 40 mg | 0 | 63 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pasireotide LAR 60 mg | 2 | 62 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cross-over to Pasireotide | 4 | 62 | |
| other | Atrioventricular block first degree | Cardiac disorders | Pasireotide LAR 40 mg | 6 | 63 | |
| other | Atrioventricular block first degree | Cardiac disorders | Pasireotide LAR 60 mg | 2 | 62 | |
| other | Atrioventricular block first degree | Cardiac disorders | Cross-over to Pasireotide | 2 | 62 | |
| other | Abdominal pain | Gastrointestinal disorders | Pasireotide LAR 40 mg | 10 | 63 |
1 to 10 of 378Source ClinicalTrials.gov
See all 378 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pasireotide LAR 40 mg | 2 | 63 |
| Total, all-cause mortality | Pasireotide LAR 60 mg | 0 | 62 |
| Total, all-cause mortality | Cross-over to Pasireotide | 0 | 62 |
| Total, other adverse events | Pasireotide LAR 40 mg | 59 | 63 |
| Total, other adverse events | Pasireotide LAR 60 mg | 58 | 62 |
| Total, other adverse events | Cross-over to Pasireotide | 61 | 62 |
| Total, serious adverse events | Pasireotide LAR 40 mg | 18 | 63 |
| Total, serious adverse events | Pasireotide LAR 60 mg | 14 | 62 |
| Total, serious adverse events | Cross-over to Pasireotide | 20 | 62 |
Source ClinicalTrials.gov
Papers2
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.
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Read this trial from software.
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