Completed PHASE3 INTERVENTIONAL 2-arm NCT00079937

Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

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

Sponsor: Novartis Pharmaceuticals

Conditions Asthma

Interventions Fluticasone Omalizumab Placebo

Updated 7 times since 2017 Last updated: Apr 9, 2012 Started: Apr 30, 2004 Primary completion: Mar 31, 2008 Completion: Mar 31, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00079937, this PHASE3 trial focuses on Asthma and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 7 times since 2004, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Apr 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Altoona, United States , Atlanta, United States , Birmingham, United States , Brick, United States , Buffalo, United States , Chicago, United States , Cincinnati, United States , Dallas, United States , Denver, United States and 41 more locations