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Clinical Trial Summary

Primary Objective:

- To evaluate safety (4 weeks)

Secondary Objectives:

- To evaluate the long-term safety (12 weeks)

- To evaluate the efficacy

- To characterize the pharmacokinetic profile


Clinical Trial Description

The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01244217
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 2010
Completion date August 2011