Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
![]() |
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: NCT01553721 |
Recruitment Status :
Completed
First Posted : March 14, 2012
Last Update Posted : April 18, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Drug: udenafil Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: udenafil
|
Drug: udenafil
Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID) |
Placebo Comparator: placebo
|
Drug: placebo
Phase IIa - placebo Phase IIb - placebo |
- Phase IIa - Pulmonary vascular resistance index(PVRI) [ Time Frame: 4 hours ]
- Phase IIb - 6-minute walk distance [ Time Frame: 16weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553721
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Chongno-gu, 28 Yongon-dong, Korea, Republic of, 110-744 | |
Samsung Medical Center | |
Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of, 135-710 | |
Severance Hospital, Yonsei University Health System | |
Special City of Seoul, Seodaemungu, 250 Seonsanno, Korea, Republic of, 120-752 | |
Chungbook national University Hospital | |
Chung-ju, Korea, Republic of | |
Chungnam National University Hospital | |
Daejeon, Korea, Republic of | |
Chonnam National University Hospital | |
Gwang-ju, Korea, Republic of | |
Pusan national University Hospital | |
Pusan, Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of | |
The catholic univ. of korea Seoul ST. MARY's hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Duk-Kyung Kim, M.D., Ph.D | Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea |
Responsible Party: | Dong-A ST Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01553721 |
Other Study ID Numbers: |
DA8159_PAH_II |
First Posted: | March 14, 2012 Key Record Dates |
Last Update Posted: | April 18, 2016 |
Last Verified: | April 2016 |
Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases |
Respiratory Tract Diseases Udenafil Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |