Trial · NCT01283542
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
NCT01283542, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma. Trials, record NCT01283542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01283542
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
- NCT number
- NCT01283542
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-functioning Pituitary Adenoma
- Interventions
- Pasireotide LAR
- First posted
- 2011-01-26
- Last updated
- 2019-04-26
- Results first posted
- 2019-04-26
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) | Baseline up to 24 weeks | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24. |
| Secondary | Tumor Volume Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Tumor Volume in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Tumor Volume Change From Baseline in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Tumor Volume Change From Baseline in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Tumor Volume Percent Change From Baseline in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Tumor Volume Percent Change From Baseline in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Secondary | Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) | Baseline up to 24 weeks | Evaluable participants required tumor volume assessment at baseline and at week 24 | percentage of participants | NUMBER |
| SECONDARY | Tumor Volume Main Phase (FAS) | baseline to week 4, 12, 24 | number of participants with evaluable data varied across visits | cm^3 | MEAN |
| SECONDARY | Tumor Volume in Extension Phase (FAS) | baseline to week 48, 72, 96 | number of participants with evaluable data varied across visits | cm^3 | MEAN |
| SECONDARY | Tumor Volume Change From Baseline in Main Phase (FAS) | baseline to week 4, 12, 24 | number of participants with evaluable data varied across visits | cm^3 | MEAN |
| SECONDARY | Tumor Volume Change From Baseline in Extension Phase (FAS) | baseline to week 48, 72, 96 | number of participants with evaluable data varied across visits | cm^3 | MEAN |
| SECONDARY | Tumor Volume Percent Change From Baseline in Main Phase (FAS) | baseline to week 4, 12, 24 | number of participants with evaluable data varied across visits | percent change | MEAN |
| SECONDARY | Tumor Volume Percent Change From Baseline in Extension Phase (FAS) | baseline to week 48, 72, 96 | number of participants with evaluable data varied across visits | percent change | MEAN |
| SECONDARY | Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS) | baseline to week 4, 12, 24 | number of participants with evaluable data varied across visits | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS) | baseline to week 4, 12, 24 | number of participants with evaluable data varied across visits | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS) | baseline to week 48, 72, 96 | number of participants with evaluable data varied across visits | percentage of patients | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group234
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 Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) | Pasireotide LAR | 16.7 | 95% Confidence Interval 2.1 to 48.4 | percentage of participants | |
| Tumor Volume Main Phase (FAS) | Pasireotide LAR | Main Baseline | 2.97 | Standard Deviation 2.53 | cm^3 |
| Tumor Volume Main Phase (FAS) | Pasireotide LAR | Main Week 4 | 4.31 | Standard Deviation 6.66 | cm^3 |
| Tumor Volume Main Phase (FAS) | Pasireotide LAR | Main Week 12 | 4.31 | Standard Deviation 6.66 | cm^3 |
| Tumor Volume Main Phase (FAS) | Pasireotide LAR | Main Week 24 | 3.39 | Standard Deviation 3.15 | cm^3 |
| Tumor Volume in Extension Phase (FAS) | Pasireotide LAR | Extension Week 48 | 3.57 | Standard Deviation 3.25 | cm^3 |
| Tumor Volume in Extension Phase (FAS) | Pasireotide LAR | Extension Week 72 | 3.12 | Standard Deviation 2.48 | cm^3 |
| Tumor Volume in Extension Phase (FAS) | Pasireotide LAR | Extension Week 96 | 1.70 | Standard Deviation 1.02 | cm^3 |
| Tumor Volume Change From Baseline in Main Phase (FAS) | Pasireotide LAR | Main Week 4 | 1.25 | 95% Confidence Interval -1.70 to 4.20 | cm^3 |
| Tumor Volume Change From Baseline in Main Phase (FAS) | Pasireotide LAR | Main Week 12 | 0.66 | 95% Confidence Interval -0.45 to 1.76 | cm^3 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Phase | STARTED | Pasireotide LAR | 20 | |
| Main Phase | Full Analysis Set (FAS) | Pasireotide LAR | 20 | |
| Main Phase | Safety Analysis Set | Pasireotide LAR | 20 | |
| Main Phase | COMPLETED | Pasireotide LAR | 13 | |
| Main Phase | NOT COMPLETED | Pasireotide LAR | 7 | |
| Extension Phase | STARTED | Pasireotide LAR | 13 | |
| Extension Phase | Full Analysis Set (FAS) | Pasireotide LAR | 13 | |
| Extension Phase | Safety Analysis Set | Pasireotide LAR | 13 | |
| Extension Phase | COMPLETED | Pasireotide LAR | 10 | |
| Extension Phase | NOT COMPLETED | Pasireotide LAR | 3 |
Source ClinicalTrials.gov
Adverse events12
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 | Abdominal distension | Gastrointestinal disorders | Pasireotide LAR | 2 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Pasireotide LAR | 2 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Pasireotide LAR | 9 | 20 | |
| other | Nausea | Gastrointestinal disorders | Pasireotide LAR | 5 | 20 | |
| other | Blood glucose increased | Investigations | Pasireotide LAR | 2 | 20 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Pasireotide LAR | 5 | 20 | |
| other | Dyslipidaemia | Metabolism and nutrition disorders | Pasireotide LAR | 2 | 20 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Pasireotide LAR | 9 | 20 | |
| other | Type 2 diabetes mellitus | Metabolism and nutrition disorders | Pasireotide LAR | 2 | 20 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pasireotide LAR | 2 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pasireotide LAR | 0 | 20 |
| Total, other adverse events | Pasireotide LAR | 17 | 20 |
| Total, serious adverse events | Pasireotide LAR | 2 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT01283542/results?page=2