Status:
COMPLETED
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.
Eligibility Criteria
Inclusion
- Patients with written informed consent prior to any study related activity
- Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period \> 2.5 µg/L and sex- and age-adjusted IGF-1 \> 1.3 x upper limit of normal (ULN)
- Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg
- Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
- Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension
Exclusion
- Patients who had received pasireotide (SOM 230) prior to enrolment
- Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
- Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
- Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
- Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
- Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
- Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
Key Trial Info
Start Date :
July 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01137682
Start Date
July 19 2010
End Date
February 28 2017
Last Update
April 5 2018
Active Locations (60)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
3
University of Texas Southwestern Medical Center Division of Hematology/Oncolog
Dallas, Texas, United States, 75235
4
Swedish Neuroscience Institute 550 17th Avenue, Suite 500
Seattle, Washington, United States, 98122