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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00376064 |
This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy
Condition | Intervention | Phase |
---|---|---|
Acromegaly |
Drug: Octreotide acetate and cabergoline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy |
Estimated Enrollment: | 100 |
Study Start Date: | March 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis | 41 61 324 1111 |
Germany | |
Recruiting | |
Muenchen, Germany | |
Recruiting | |
Berlin, Germany | |
Recruiting | |
Essen, Germany | |
Recruiting | |
Erlangen, Germany | |
Recruiting | |
Tubingen, Germany | |
Recruiting | |
Koln, Germany | |
Recruiting | |
Leipzig, Germany | |
Recruiting | |
Wurzburg, Germany | |
Recruiting | |
Aachen, Germany | |
Recruiting | |
Marburg, Germany | |
Recruiting | |
Heidelberg, Germany | |
Recruiting | |
Bochum, Germany | |
Recruiting | |
Regensburg, Germany | |
Recruiting | |
Oldenburg, Germany | |
Recruiting | |
Greifswald, Germany | |
Recruiting | |
Ulm, Germany |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CSMS995BDE16 |
Study First Received: | September 13, 2006 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00376064 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Growth hormone (GH) IGF-1 Acromegaly Pituitary adenoma |
Brain tumor Brain cancer Octreotide acetate |
Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Central Nervous System Diseases Endocrine System Diseases Octreotide Brain Diseases Bone Diseases |
Somatostatin Brain Neoplasms Dopamine Musculoskeletal Diseases Endocrinopathy Cabergoline Adenoma Acromegaly |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Anti-Dyskinesia Agents Physiological Effects of Drugs Nervous System Diseases Gastrointestinal Agents |
Antiparkinson Agents Dopamine Agonists Pharmacologic Actions Hyperpituitarism Therapeutic Uses Dopamine Agents Central Nervous System Agents |