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Safety and Efficacy of SA09012 in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740986
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
SamA Pharmaceutical Co., Ltd

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date November 16, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Mean change from baseline of PEF(Peak Expiratory Flow)at week 6 [ Time Frame: 6 week treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
  • Mean change from baseline in FEV1 at week 6 [ Time Frame: 6 week treatment period ]
  • Mean change from baseline in ACT(Asthma Control Test) at week 6 [ Time Frame: 6 week treatment period ]
  • Safety assessment(Comparison of the adverse event profiles throughout the course of the study) [ Time Frame: 6 week treatment period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Mean change from baseline in FEV1 at week 6 [ Time Frame: 6 week treatment period ]
  • Mean change from baseline in ACT(Asthma Control Test) at week 6 [ Time Frame: 6 week treatment period ]
  • Safety assessment [ Time Frame: 6 week treatment period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SA09012 in Asthma
Official Title  ICMJE Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
Brief Summary Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Mild to Moderate Bronchial Asthma
Intervention  ICMJE
  • Drug: SA09012 Low dose
    Tablet, b.i.d
  • Drug: SA09012 High dose
    Tablet, b.i.d
  • Drug: Placebo
    Tablet, b.i.d
Study Arms  ICMJE
  • Experimental: SA09012 Low dose
    Intervention: Drug: SA09012 Low dose
  • Experimental: SA09012 High dose
    Intervention: Drug: SA09012 High dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2015)
225
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
234
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis or presence of asthma within 3 months of the prestudy visit

    1. Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
    2. Increase in FEV1 ≥ 12% and ≥ 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
  • FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
  • Having signed an informed consent

Exclusion Criteria:

  • Patient who has severe asthma
  • Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply
  • Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit
  • Patient with more than 10 pack year of cigarettes history
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740986
Other Study ID Numbers  ICMJE SA09012-P2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SamA Pharmaceutical Co., Ltd
Study Sponsor  ICMJE SamA Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young Kyoon Kim, MD Seoul ST. Mary's Hospital The Catholic University of Korea
PRS Account SamA Pharmaceutical Co., Ltd
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP