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NCT01287039 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
A Phase 3 study of Eosinophilic Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 489
- Enrollment target
- 20
- Study locations
NCT01287039: Completed Phase 3 study of Eosinophilic Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01287039 is a Phase 3 study of Eosinophilic Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 489 participants, roughly in line with the 450-participant average among 4 other Eosinophilic Asthma trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287039, a Phase 3 study of Eosinophilic Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 489 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.
Primary Outcome
An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: * use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids. * asthma-related emergency treatment, such as an unscheduled v
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Reslizumab
Study Locations (20)
California
- Teva Investigational Site 61 - Los Angeles
- Teva Investigational Site 37 - Orange
- Teva Investigational Site 56 - San Diego
Florida
- Teva Investigational Site 52 - DeBary
- Teva Investigational Site 55 - Miami
- Teva Investigational Site 18 - Valrico
Kentucky
- Teva Investigational Site 49 - Lexington
- Teva Investigational Site 65 - Louisville
New York
- Teva Investigational Site 68 - Rochester
- Teva Investigational Site 60 - The Bronx
Ohio
- Teva Investigational Site 31 - Cincinnati
- Teva Investigational Site 62 - Columbus
Arizona
- Teva Investigational Site 58 - Scottsdale
Colorado
- Teva Investigational Site 34 - Colorado Springs
Massachusetts
- Teva Investigational Site 51 - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 489 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01287039 record still lists
NCT01287039 is an interventional study that assigns participants to a tested intervention. The registered 489 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 450-participant average among 4 other Eosinophilic Asthma trials with a reported enrollment target.
The record links to 1 condition, with Eosinophilic Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01287039 names 20 study sites across 13 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01287039 about?
NCT01287039 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma". This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.
What is the current status of trial NCT01287039?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 489 participants. The study started on 2011-04. Estimated completion is 2014-03.
What conditions does trial NCT01287039 study?
This clinical trial studies the following conditions: Eosinophilic Asthma.
What interventions are being tested in trial NCT01287039?
The interventions under investigation include: Placebo (DRUG), Reslizumab (DRUG).
Who is sponsoring clinical trial NCT01287039?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01287039 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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