Trials / Completed
CompletedNCT01519700
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EP2006 | Eligible patients will be teated with EP2006 |
| DRUG | Filgrastim | Eligible patients will be teated with Filgrastim |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2012-01-27
- Last updated
- 2015-05-06
- Results posted
- 2015-04-07
Locations
26 sites across 6 countries: Czechia, Hungary, Latvia, Russia, Slovakia, Ukraine
Source: ClinicalTrials.gov record NCT01519700. Inclusion in this directory is not an endorsement.