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Safety and Efficacy of YHD001 in Asthma

NCT01424124 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-07-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-06-30
Completion
2014-01-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
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 NCT01424124 on ClinicalTrials.gov