Know Cancer

forgot password

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Inclusion Criteria

Inclusion criteria:

- 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

Exclusion criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Mean growth hormone (GH) level and insulin like growth factor-1 (IGF-1) level,12 months.

Outcome Time Frame:

At 12 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

June 2014

Related Keywords:

  • Acromegaly
  • Acromegaly,
  • adult,
  • growth hormone,
  • insulin-like growth factor I,
  • somatostatin analogue
  • Acromegaly



Baylor College of Medicine Houston, Texas  77030
Allegheny Endocrinology Associates Pittsburgh, Pennsylvania  15212
Stanford University Medical Center Stanford Cancer Center (3) Stanford, California  94304
Swedish Medical Center Dept.ofSeattle Neuroscience(2) Seattle, Washington  
Cedars Sinai Medical Center The Pituitary Center Los Angeles, California  90048
UCLA/ University of California Los Angeles Division of Endocrinology Los Angeles, California  90095
University of Florida SC Gainesville, Florida  32610
Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv. Baltimore, Maryland  21205
University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes Ann Arbor, Michigan  48109-0944
Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur New York, New York  10032
Northport VA Medical Center Northport, New York  11768
Oregon Health & Sciences University DeptofOregonHealth&Sciences(3) Portland, Oregon  97201
University of Texas Southwestern Medical Center Danziger Research Bldg. Dallas, Texas  75390-8527
MD Anderson Cancer Center/University of Texas Endocrine Neoplasia & Hormonal Houston, Texas  77030-4009