Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:   The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  

Publications of Results:
Publications automatically indexed to this study:

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00116688     History of Changes
Other Study ID Numbers:	20030213
Study First Received:	June 30, 2005
Results First Received:	March 4, 2011
Last Updated:	March 4, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines;   Belgium: Directorate-General for Medicinal Products;   Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment;   Belgium: FPS of Public Health, Food Chain Security and Environment;   Belgium: Pharmaceutical Inspectorate;   Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement;   Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement;   Canada: Health Canada;   Canada: Health Products and Food Branch;   Canada: Institutional Review Board;   Czech Republic: State Institute for Drug Control;   Czech Republic: Statni ustav pro kontrolu leciv;   EU: CHMP;   European Union: European Medicines Agency;   France and Sweden: European Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   France: CCPPRB Central Ethics Committee;   France: Ministry of Health;   Germany: Federal Institute for Drugs and Medical Devices;   Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe;   Italy: Local Ethics Committees;   Italy: Ministry of Health;   Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research;   Netherlands: Medicines Evaluation Board;   Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider;   Austria: Secretariat of Health;   Spain: Agencia Española de Medicamentos y Productos Sanitarios;   Spain: Spanish Agency of Medicines;   Spain: Spanish Drug Agency;   Switzerland: Agency for Therapeutic Products;   Switzerland: Local Ethics Committee;   Switzerland: Swissmedic (Swiss Agency for Therapeutic Products);   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Poland: Drug Institut;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   United States: Food and Drug Administration;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Australia: Human Research Ethics Committee;   Australia: Therapeutic Goods Administration;   Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information;   Austria: Bundesamt fur Sicherheit im Gesundheitswesen;   Austria: Bundesamt für Sicherheit im Gesundheitswesen;   Austria: Central Ethics Committee;   Austria: Competant Authority;   Austria: Federal Ministry for Health and Women