Trial · NCT02354508
Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
NCT02354508, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-12-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues. Trials, record NCT02354508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02354508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
- NCT number
- NCT02354508
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 123 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acromegaly
- Interventions
- Pasireotide LAR
- First posted
- 2015-02-03
- Last updated
- 2019-12-10
- Other registries' IDs
- eudract:2014-002630-31
- Results first posted
- 2019-12-04
- Limitations and caveats
The study is a single-arm study to evaluate the safety \& efficacy of pasireotide LAR in patients with inadequately controlled acromegaly who were previously on somatostatin analogues: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | Week 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36. |
| Primary | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg | Week 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg. |
| Primary | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Wek 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36. |
| Primary | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Week 36 | Percentage of patients who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment, type of therapy and overall. |
| Primary | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status | Week 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, overall by baseline diabetic status. |
| Primary | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF | Week 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF) |
| Secondary | Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36 | Baseline, week 36 | Core phase - Changes in mean GH from study baseline to week 36. |
| Secondary | Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36 | Baseline, week 36 | Core phase - Changes in standardized IGF-1 from study baseline to week 36. |
| Secondary | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12, Week 24, Week 36 | Percentage of participants achieving GH \<1 μg/L and IGF-1 \<ULN at weeks 12 and 24 overall and by GH level at screening. |
| Secondary | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Weeks 12, 24 & 36 | Percentage of participants achieving IGF-1 \<ULN at weeks 12, 24 \& 36. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | Week 36 | Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. | Percentage of participants | NUMBER |
| PRIMARY | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg | Week 36 | Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. For these patients the Pasireotide LAR dose was uptitrated to 60 mg before Week 36. | Percentage of participants | NUMBER |
| PRIMARY | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Wek 36 | Per-Protocol Set (PPS): consisted of a subset of the patients in the FAS who were compliant with requirements of the clinical study protocol. The protocol deviations criteria were defined prior to database lock. Per-protocol analysis was performed during the core phase, but not during the extension phase. | Percentage of participants | NUMBER |
| PRIMARY | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Week 36 | Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. | Percentage of participants | NUMBER |
| PRIMARY | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg | Week 36 | Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. For these patients the Pasireotide LAR dose was uptitrated to 60 mg any time during the study. | Percentage of participants | NUMBER |
| PRIMARY | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status | Week 36 | Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. | Percentage of participants | NUMBER |
| PRIMARY | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF | Week 36 | Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. | Percentage of participants | NUMBER |
| SECONDARY | Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36 | Baseline, week 36 | FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. | percentage change | MEAN |
| SECONDARY | Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36 | Baseline, week 36 | FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. | percentage change | MEAN |
| SECONDARY | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12, Week 24, Week 36 | FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. | Percentage of participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group427
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | Lanreotide 120 mg | 14.6 | 95% Confidence Interval 5.57 to 29.17 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | Octreotide 30 mg | 13.8 | 95% Confidence Interval 3.89 to 31.66 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | Octreotide 40 mg | 15.1 | 95% Confidence Interval 6.75 to 27.59 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | Pasireotide LAR Overall | 14.6 | 95% Confidence Interval 8.91 to 22.14 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg | Up-titrated to Pasireotide LAR 60 mg | 6.7 | 95% Confidence Interval 2.49 to 13.95 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Pasireotide LAR Overall | 15.7 | 95% Confidence Interval 9.24 to 24.22 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Lanreotide 120 mg | 7.7 | 95% Confidence Interval 0.95 to 25.13 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Octreotide 30 mg | 13.0 | 95% Confidence Interval 2.78 to 33.59 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Octreotide 40 mg | 20.5 | 95% Confidence Interval 9.30 to 36.46 | Percentage of participants | |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Pasireotide LAR Monotherapy | 17.1 | 95% Confidence Interval 9.43 to 27.47 | Percentage of participants |
1 to 10 of 427Source ClinicalTrials.gov
See all 427 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Core Phase | STARTED | Lanreotide 120 mg | 41 | |
| Period 1: Core Phase | STARTED | Octreotide 30 mg | 29 | |
| Period 1: Core Phase | STARTED | Octreotide 40 mg | 53 | |
| Period 1: Core Phase | COMPLETED | Lanreotide 120 mg | 39 | |
| Period 1: Core Phase | COMPLETED | Octreotide 30 mg | 27 | |
| Period 1: Core Phase | COMPLETED | Octreotide 40 mg | 47 | |
| Period 1: Core Phase | NOT COMPLETED | Lanreotide 120 mg | 2 | |
| Period 1: Core Phase | NOT COMPLETED | Octreotide 30 mg | 2 | |
| Period 1: Core Phase | NOT COMPLETED | Octreotide 40 mg | 6 | |
| Period 2: Extension Phase | STARTED | Lanreotide 120 mg | 26 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events88
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 | Up-titrated to Pasireotide LAR 60 mg | 11 | 92 | |
| other | Anaemia | Blood and lymphatic system disorders | Pasireotide LAR Overall | 13 | 123 | |
| other | Sinus bradycardia | Cardiac disorders | Up-titrated to Pasireotide LAR 60 mg | 8 | 92 | |
| other | Sinus bradycardia | Cardiac disorders | Pasireotide LAR Overall | 9 | 123 | |
| other | Abdominal distension | Gastrointestinal disorders | Up-titrated to Pasireotide LAR 60 mg | 6 | 92 | |
| other | Abdominal distension | Gastrointestinal disorders | Pasireotide LAR Overall | 6 | 123 | |
| other | Abdominal pain | Gastrointestinal disorders | Up-titrated to Pasireotide LAR 60 mg | 10 | 92 | |
| other | Abdominal pain | Gastrointestinal disorders | Pasireotide LAR Overall | 12 | 123 | |
| other | Diarrhoea | Gastrointestinal disorders | Up-titrated to Pasireotide LAR 60 mg | 16 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Pasireotide LAR Overall | 22 | 123 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Up-titrated to Pasireotide LAR 60 mg | 0 | 92 |
| Total, all-cause mortality | Pasireotide LAR Overall | 0 | 123 |
| Total, other adverse events | Up-titrated to Pasireotide LAR 60 mg | 83 | 92 |
| Total, other adverse events | Pasireotide LAR Overall | 112 | 123 |
| Total, serious adverse events | Up-titrated to Pasireotide LAR 60 mg | 6 | 92 |
| Total, serious adverse events | Pasireotide LAR Overall | 12 | 123 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32117045 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Up-titrated to Pasireotide LAR 60 mg vs Pasireotide LAR Overall: deaths from any cause | Trial comparisons |
| Up-titrated to Pasireotide LAR 60 mg vs Pasireotide LAR Overall: serious adverse events | 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.
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/NCT02354508
GET https://conductscience.org/api/trials/v1/NCT02354508/registered?page=2