Trial · NCT00600886
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
NCT00600886, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly. Trials, record NCT00600886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00600886
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
- NCT number
- NCT00600886
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 358 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acromegaly
- Interventions
- Pasireotide, Octreotide
- First posted
- 2008-01-25
- Last updated
- 2017-07-02
- Other registries' IDs
- eudract:2007-001972-36
- Results first posted
- 2015-01-30
Source ClinicalTrials.gov
Registered outcomes26
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 Level to <2.5 μg/L and the Normalization of IGF-1 | 12 months | Percentage of participants with a reduction of mean GH levels to \<2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated. |
| Secondary | Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L | 12 Months | Percentage of participants with a reduction of mean GH levels to \< 2.5μg/L (based on a 5-point 2-hour profile). Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated. |
| Secondary | Change From Baseline in Tumor Volume at 12 Months | Baseline, 12 Months | Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated. |
| Secondary | Percentage of Participants With Normalization of IGF-1 | 12 Months | Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated. |
| Secondary | Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 | Months 3, 6, 9, 12, 16, 19, 22, 25 | Percentage of participants with a reduction of mean GH levels to \< 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core \& ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.) |
| Secondary | Summary of Mean GH Values | Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25 | Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). |
| Secondary | Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) ) | Up to 26 months | Time to first response for patients achieving a reduction of mean GH level to \< 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). |
| Secondary | Severity Scores of Acromegaly Symptoms | Baseline, Months 12, 25 | Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). |
| Secondary | Ring Size | Baseline, Months 12, 25 | Ring size (based on jeweler's finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). |
| Secondary | Health-related Quality-of-life as Measured by the AcroQoL Questionnaire | Baseline, Months 12, 25 | Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
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 Level to <2.5 μg/L and the Normalization of IGF-1 | 12 months | Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH and/or IGF-1 levels at M12 were imputed using data obtained at or after M6 by the last observation carried forward method; otherwise, Pts were considered as non-responders. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L | 12 Months | FAS: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Tumor Volume at 12 Months | Baseline, 12 Months | Full Analysis Set (FAS): All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization. | mm^3 | MEAN |
| SECONDARY | Percentage of Participants With Normalization of IGF-1 | 12 Months | Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing IGF-1 levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as nonresponders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 | Months 3, 6, 9, 12, 16, 19, 22, 25 | Full Analysis Set: All patients who were randomized into the study. | Percentage of participants | NUMBER |
| SECONDARY | Summary of Mean GH Values | Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25 | Full Analysis Set: All patients who were randomized into the study. | μg/L | MEAN |
| SECONDARY | Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) ) | Up to 26 months | Full Analysis Set: All patients who were randomized into the study. | Weeks | MEDIAN |
| SECONDARY | Severity Scores of Acromegaly Symptoms | Baseline, Months 12, 25 | Full Analysis Set: All patients who were randomized into the study. | scores on a scale | MEAN |
| SECONDARY | Ring Size | Baseline, Months 12, 25 | Full Analysis Set: All patients who were randomized into the study. | ring zize | MEAN |
| SECONDARY | Health-related Quality-of-life as Measured by the AcroQoL Questionnaire | Baseline, Months 12, 25 | Full Analysis Set: All patients who were randomized into the study. | Score on a scale | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group336
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 Level to <2.5 μg/L and the Normalization of IGF-1 | Pasireotide LAR (Core) | Overall | 31.3 | 95% Confidence Interval 24.5 to 38.7 | Percentage of Participants |
| Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 | Octreotide LAR (Core) | Overall | 19.2 | 95% Confidence Interval 13.8 to 25.7 | Percentage of Participants |
| Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 | Pasireotide LAR (Core) | Post Surgery | 39.4 | 95% Confidence Interval 28.0 to 51.7 | Percentage of Participants |
| Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 | Octreotide LAR (Core) | Post Surgery | 21.8 | 95% Confidence Interval 13.2 to 32.6 | Percentage of Participants |
| Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 | Pasireotide LAR (Core) | De novo | 25.7 | 95% Confidence Interval 17.7 to 35.2 | Percentage of Participants |
| Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 | Octreotide LAR (Core) | De novo | 17.3 | 95% Confidence Interval 10.6 to 26.0 | Percentage of Participants |
| Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L | Pasireotide LAR (Core) | Overall | 48.3 | 95% Confidence Interval 40.7 to 55.9 | Percentage of participants |
| Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L | Octreotide LAR (Core) | Overall | 51.6 | 95% Confidence Interval 44.1 to 59.1 | Percentage of participants |
| Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L | Pasireotide LAR (Core) | Post surgery | 52.1 | 95% Confidence Interval 39.9 to 64.1 | Percentage of participants |
| Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L | Octreotide LAR (Core) | Post surgery | 51.3 | 95% Confidence Interval 39.7 to 62.8 | Percentage of participants |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase - Full Analysis Set (FAS) | STARTED | Pasireotide LAR | 176 | |
| Core Phase - Full Analysis Set (FAS) | STARTED | Octreotide LAR | 182 | |
| Core Phase - Full Analysis Set (FAS) | Did Not Enter Extension | Pasireotide LAR | 29 | |
| Core Phase - Full Analysis Set (FAS) | Did Not Enter Extension | Octreotide LAR | 29 | |
| Core Phase - Full Analysis Set (FAS) | Entered Extension, Crossed Over | Pasireotide LAR | 38 | |
| Core Phase - Full Analysis Set (FAS) | Entered Extension, Crossed Over | Octreotide LAR | 81 | |
| Core Phase - Full Analysis Set (FAS) | Entered Ext Continued Same Treatment | Pasireotide LAR | 74 | |
| Core Phase - Full Analysis Set (FAS) | Entered Ext Continued Same Treatment | Octreotide LAR | 46 | |
| Core Phase - Full Analysis Set (FAS) | COMPLETED | Pasireotide LAR | 141 | |
| Core Phase - Full Analysis Set (FAS) | COMPLETED | Octreotide LAR | 156 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events1,134
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 - up to 26 Months | 14 | 178 | |
| other | Anaemia | Blood and lymphatic system disorders | Octreotide LAR - up to 26 Months | 10 | 180 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossed Over to Pasireotide LAR - up to 26 Months | 6 | 81 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossed Over to Octreotide LAR - up to 26 Months | 1 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | Pasireotide LAR - up to EOS | 19 | 178 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossed Over to Pasireotide LAR - up to EOS | 8 | 81 | |
| other | Sinus bradycardia | Cardiac disorders | Pasireotide LAR - up to 26 Months | 13 | 178 | |
| other | Sinus bradycardia | Cardiac disorders | Octreotide LAR - up to 26 Months | 10 | 180 | |
| other | Sinus bradycardia | Cardiac disorders | Crossed Over to Pasireotide LAR - up to 26 Months | 2 | 81 | |
| other | Sinus bradycardia | Cardiac disorders | Crossed Over to Octreotide LAR - up to 26 Months | 1 | 38 |
1 to 10 of 1,134Source ClinicalTrials.gov
See all 1,134 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pasireotide LAR - up to 26 Months | ||
| Total, all-cause mortality | Octreotide LAR - up to 26 Months | ||
| Total, all-cause mortality | Crossed Over to Pasireotide LAR - up to 26 Months | ||
| Total, all-cause mortality | Crossed Over to Octreotide LAR - up to 26 Months | ||
| Total, all-cause mortality | Pasireotide LAR - up to EOS | ||
| Total, all-cause mortality | Crossed Over to Pasireotide LAR - up to EOS | ||
| Total, other adverse events | Pasireotide LAR - up to 26 Months | 169 | 178 |
| Total, other adverse events | Octreotide LAR - up to 26 Months | 161 | 180 |
| Total, other adverse events | Crossed Over to Pasireotide LAR - up to 26 Months | 74 | 81 |
| Total, other adverse events | Crossed Over to Octreotide LAR - up to 26 Months | 33 | 38 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
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/NCT00600886
GET https://conductscience.org/api/trials/v1/NCT00600886/registered?page=2