Trials / Completed
CompletedNCT01424124
Safety and Efficacy of YHD001 in Asthma
Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 Following 8 Weeks Oral Administration of YHD001 in Patients With Partially Controlled Asthma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Yuhan Corporation · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma. The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.
Detailed description
Singulair: Montelukast sodium (leukotriene modulator)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | YHD001 dose level 1 | Tablet, three times daily / 8 weeks |
| DRUG | YHD001 dose level 2 | Tablet, three times daily / 8 weeks |
| DRUG | Singulair | Tablet, one times daily / 8 weeks |
| DRUG | Placebo | Tablet, one times daily / 7 days |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-06-01
- Completion
- 2014-01-01
- First posted
- 2011-08-26
- Last updated
- 2014-07-10
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01424124. Inclusion in this directory is not an endorsement.