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Tracking Information | |||||
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First Received Date † | November 17, 2006 | ||||
Last Updated Date | November 17, 2006 | ||||
Start Date † | |||||
Current Primary Outcome Measures † |
Incidence of all serious adverse events. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO) | ||||
Official Title † | A Multicenter, Randomized, Controlled, Open-Label Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Subjects Already Treated With Other Therapies (ALTO) | ||||
Brief Summary | This was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899 subjects were randomized (2:1) to either the active treatment group or the control group. Upon successful completion of the screening period (~2 weeks), each subject entered the 24 week study. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Asthma | ||||
Intervention † | Drug: Xolair (omalizumab) | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 1899 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 6 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00401596 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Genentech | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Genentech | ||||
Verification Date | November 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |