ClinicalTrials.gov Identifier: NCT04076462
Sponsor: Camurus AB
Information provided by (Responsible Party): Camurus AB
|Actual Study Start Date :||August 14, 2019|
|Estimated Primary Completion Date:||September 2021|
|Estimated Study Completion Date:||October 2021|
Currently two global trials are recruiting patients diagnosed with acromegaly in the United States. These trials evaluate the efficacy, safety and tolerability of CAM2029, a new long-acting investigational formulation of octreotide. For more information on the trials, please follow the link to the Acromegaly&ME site
Clinical trial HS-18-633: A Phase 3, Randomized, Double-blind, Placebo controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
This trial (ClinicalTrials.gov Identifier: NCT04076462) is recruiting patients diagnosed with acromegaly who have been receiving regular treatment with octreotide or lanreotide. Patients that have been on a stable dose (of octreotide or lanreotide) for at least 3 months and have well-controlled levels of insulin-like growth factor 1 (IGF-1) may be eligible to participate.
Clinical trial HS-19-647: A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
This trial (ClinicalTrials.gov Identifier: NCT04125836) is recruiting patients diagnosed with acromegaly who have been receiving regular treatment with octreotide or lanreotide for at least 3 months. Patients can also have previously received radiotherapy (irradiation) treatment. Levels of insulin-like growth factor 1 (IGF-1) do not need to be well-controlled.
Patients who previously participated in and completed the HS-18-633 trial will be invited to continue participation for 6 months in the HS-19-647 trial.
Camurus AB is a Swedish biopharmaceutical company committed to developing long-acting medicines for the treatment of severe and chronic conditions.
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