Trials / Terminated
TerminatedNCT01907763
Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
A 12-week, Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- SK Chemicals Co., Ltd. · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks.
Detailed description
A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOTB07 200mg | |
| DRUG | SOTB07 400mg | |
| DRUG | SOTB 200mg placebo | Placebo of SOTB07 200mg |
| DRUG | SOTB 400mg placebo | Placebo of SOTB07 400mg |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-10-01
- First posted
- 2013-07-25
- Last updated
- 2016-01-28
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01907763. Inclusion in this directory is not an endorsement.