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Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

NCT01907763 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2016-01-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SOTB07 200mg

DRUG

SOTB07 400mg

DRUG

SOTB 200mg placebo

Placebo of SOTB07 200mg

DRUG

SOTB 400mg placebo

Placebo of SOTB07 400mg

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sangheon Cho, professor · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-10-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01907763 on ClinicalTrials.gov