Trial · NCT01137682
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| SECONDARY | Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | CORE baseline up to approximately 268 weeks | weeks | MEDIAN | |
| SECONDARY | Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly | CORE baseline up to approximately 268 weeks | weeks | MEDIAN | |
| SECONDARY | Change From Baseline in AcroQoL Total Scores 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 available for analysis differed from visit to visit | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE Baseline and extension baseline up to approximately 268 weeks | completed and valid questionnaires at visits | scores on a scale | MEAN |
| SECONDARY | Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Extension baseline up to approximately 196 weeks | Available data for analysis varies at visits | mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01137682/outcomes