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Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

This study is currently recruiting participants.
Verified March 2012 by Dong-A Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01553721
First received: January 1, 2012
Last updated: March 12, 2012
Last verified: March 2012
History of Changes

January 1, 2012
March 12, 2012
August 2011
August 2013   (final data collection date for primary outcome measure)
  • Phase IIa - Pulmonary vascular resistance index(PVRI) [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Phase IIb - 6-minute walk distance [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01553721 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: udenafil

    Phase IIa - Udenafil Dose 1, Dose 2(QD)

    Phase IIb - Udenafil Dose 1 or Dose 2(BID)

  • Drug: placebo
    Phase IIa - placebo Phase IIb - placebo
  • Experimental: udenafil
    1. Phase IIa Experimental : Udenafil Dose 1, Dose 2
    2. Phase IIb Experimental : Udenafil Dose 1 or Dose 2
    Intervention: Drug: udenafil
  • Placebo Comparator: placebo
    1. Phase IIa Placebo Comparator : Placebo
    2. Phase IIb Placebo Comparator : Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

• Subjects aged 18 and over who have any of the following diseases

  • primary Pulmonary Arterial Hypertension
  • secondary Pulmonary Arterial Hypertension caused by connective tissue disease
  • [Phase IIb] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome)

Exclusion Criteria:

  • Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria
  • BMI(Body Mass Index) < 18.5kg/m2
  • Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>170/100mmHg)
  • Creatinine clearance ≤ 30mL/min
  • History of non-arteritic anterior ischemic optic neuropathy(NAION)
Both
18 Years and older
No
Contact: Duk-Kyung Kim, M.D., Ph.d. +82-2-3410-3419 dkkim@skku.edu
Korea, Republic of
 
NCT01553721
DA8159_PAH_II
Yes
Dong-A Pharmaceutical Co., Ltd.
Dong-A Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Duk-Kyung Kim, M.D., Ph.D Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea
Dong-A Pharmaceutical Co., Ltd.
March 2012

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