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NCT00079937 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
A Phase 3 study of Asthma, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 628
- Enrollment target
- 20
- Study locations
NCT00079937 is a Phase 3 study of Asthma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 628 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT00079937, a Phase 3 study of Asthma, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 628 participants
- Enrollment target
- 20
- Study locations
Study Summary
A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluticasone
- DRUG Omalizumab
Study Locations (20)
California
- Allergy and Asthma Specialists Medical Group - Huntington Beach
- Pediatric Care and Medical Group - Huntington Beach
- West Coast Clinical Trials - Long Beach
- Southern California Research Center - Mission Viejo
- Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology - Orange
- CA Allergy & Asthma Med Group - Palmdale
- Dr. Joann Blessing-Moore - Palo Alto
- Integrated Research Group - Riverside
- Allergy Associates Medical Group - San Diego
- Allergy and Asthma Medical Group & Research Center - San Diego
- Allergy and Asthma Associates of Santa Clara Valley RC - San Jose
- 1304 15th St - Santa Monica
- Bensch Research Associates - Stockton
- Allergy & Asthma Med Group of Diablo Valley CR - Walnut Creek
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
- Clinical Research Center - Little Rock
Alabama
- Alabama Allergy and Asthma Center - Birmingham
Colorado
- National Jewish Medical and Research Center - Denver
Florida
- Miami Children's Hospital - Miami
Georgia
- Georgia Pollens - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2004-04 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00079937
The ClinicalTrials.gov registry entry for NCT00079937 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 628 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00079937 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT00079937 about?
NCT00079937 is a clinical study titled "Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma". A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. Th...
What is the current status of trial NCT00079937?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 628 participants. The study started on 2004-04. Estimated completion is 2008-03.
What conditions does trial NCT00079937 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT00079937?
The interventions under investigation include: Placebo (DRUG), Fluticasone (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT00079937?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00079937 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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