Trials / Completed
CompletedNCT00171730
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pasireotide |
Timeline
- Start date
- 2004-08-24
- Primary completion
- 2013-12-06
- Completion
- 2013-12-06
- First posted
- 2005-09-15
- Last updated
- 2021-09-05
- Results posted
- 2021-06-02
Locations
10 sites across 7 countries: United States, Australia, Belgium, France, Germany, Italy, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00171730. Inclusion in this directory is not an endorsement.