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An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00171730
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. This study will assess the long-term safety and efficacy of pasireotide in patients with acromegaly.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Pasireotide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension to a Multi-center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients
Study Start Date : August 2004
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pasireotide s.c. (SOM230) Drug: Pasireotide


Outcome Measures

Primary Outcome Measures :
  1. Circulating GH- and IGF-1 concentrations measured every 4 weeks [ Time Frame: Every 6 months ]

Secondary Outcome Measures :
  1. Long-term safety and efficacy of multiple doses of Pasireotide s.c. [ Time Frame: Every 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed all four treatment regimens in the core study CSOM230B2201 and achieved biochemical control in GH and IGF-1 levels after at least one month of pasireotide administration at any of the three doses
  • Patients who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201

Exclusion Criteria:

  • Patients who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201
  • Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201 Patients who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B2201

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171730


Locations
United States, California
Cedars Sinai Medical Center Dept. of Pituitary Ctr.
Los Angeles, California, United States, 90048
United States, Michigan
University of Michigan Health System StudyCoordinatorCSOM230B2201E1
Ann Arbor, Michigan, United States, 48109
United States, New York
NYU / VA Medical Center
New York, New York, United States, 10010
Australia, Queensland
Novartis Investigative Site
Woolloongabba, Queensland, Australia, 4102
Belgium
Novartis Investigative Site
Edegem, Belgium, 2650
France
Novartis Investigative Site
Toulouse Cédex 4, France, 31043
Germany
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Muenchen, Germany, 80336
Italy
Novartis Investigative Site
Napoli, Italy, 80131
Switzerland
Novartis Investigative Site
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171730     History of Changes
Other Study ID Numbers: CSOM230B2201E1
2004-002849-12 ( EudraCT Number )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Acromegaly
Pasireotide
GH
IGF-1

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs