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NCT00600886 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 358
- Enrollment target
NCT00600886: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00600886 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 358 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00600886, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 358 participants
- Enrollment target
Study Summary
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months. Following one year of treatment patients could proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.
Primary Outcome
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.
Interventions
- DRUG Pasireotide
- DRUG Octreotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2008-02-11 |
| Est. Completion | 2016-03-11 |
| Phase | Phase 3 |
What the finished NCT00600886 record still lists
NCT00600886 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Pasireotide is the first listed.
NCT00600886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00600886 about?
NCT00600886 is a clinical study titled "Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly". The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the tw...
What is the current status of trial NCT00600886?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 358 participants. The study started on 2008-02-11. Estimated completion is 2016-03-11.
What interventions are being tested in trial NCT00600886?
The interventions under investigation include: Pasireotide (DRUG), Octreotide (DRUG).
Who is sponsoring clinical trial NCT00600886?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00600886's enrollment target sits among peer trials
358 1022nd of 2000 higher than 978 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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