Clinical trial
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With…
NCT00079937 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00079937 |
|---|---|
| Title | Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma |
| Official title | A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Asthma |
| Intervention type | Drug |
| Interventions | Omalizumab, Placebo, Fluticasone |
| Enrollment | 628 |
| Start date | Apr 1, 2004 |
| Primary completion | Mar 1, 2008 |
| Completion | Mar 1, 2008 |
| First posted | Mar 22, 2004 |
| Last update posted | Apr 11, 2012 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: