Brief Title
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
Official Title
A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.
Secondary Outcome
Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
Condition
Acromegaly
Intervention
Pasireotide
Study Arms / Comparison Groups
Pasireotide LAR 40 mg
Description: Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
198
Start Date
July 19, 2010
Completion Date
February 28, 2017
Primary Completion Date
January 22, 2013
Eligibility Criteria
Inclusion Criteria: 1. Patients with written informed consent prior to any study related activity 2. 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) 3. 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 4. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery 5. 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 Criteria: 1. Patients who had received pasireotide (SOM 230) prior to enrolment 2. 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. 3. Patients who had compression of the optic chiasm causing acute clinically significant visual field defects 4. Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression 5. Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening). 6. Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening). 7. Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT01137682
Organization ID
CSOM230C2402
Secondary IDs
EUDRACT 2009-016722-13
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
April 2018