Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Completed · Phase 3

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT00600886

Run by

Novartis Pharmaceuticals

People needed

358

Starts

2008-02-11

Expected to finish

2016-03-11

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with active acromegaly (based on elevated GH and IGF-1 levels)
• Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
• Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity

You may not qualify if…

• Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
• Patients with compression of the optic chiasm causing any visual field defect
• Patients who have received pituitary irradiation within the last ten years prior to visit 1
• Poorly controlled diabetic patients
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of California at Los Angeles Division of Endocrinology — Los Angeles, California, United States
• Stanford University Medical Center Stanford Cancer Center (3) — Stanford, California, United States
• University of Florida SC — Gainesville, Florida, United States
• Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv. — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes — Ann Arbor, Michigan, United States
• Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur — New York, New York, United States
• Northport VA Medical Center CSOM230C2305 — Northport, New York, United States
• Oregon Health & Sciences University DeptofOregonHealth&Sciences(3) — Portland, Oregon, United States
• Allegheny Endocrinology Associates — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical Center Danziger Research Bldg. — Dallas, Texas, United States
• University of Texas/MD Anderson Cancer Center Regulatory -12 — Houston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Swedish Medical Center Dept.ofSeattle Neuroscience(2) — Seattle, Washington, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Capital Federal, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Novartis Investigative Site — Brasília, Federal District, Brazil
• Novartis Investigative Site — São Luís, Maranhão, Brazil
• Novartis Investigative Site — Curitiba, Paraná, Brazil
• Cedars Sinai Medical Center The Pituitary Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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