Clinical trial NCT01553721: Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Phase IIa - Pulmonary vascular resistance index(PVRI)
timeFrame: 4 hours
measure: Phase IIb - 6-minute walk distance
timeFrame: 16weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Chongno-gu, 28 Yongon-dong
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-Gu, Irwon-Dong 50
city: Special City of Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seodaemungu, 250 Seonsanno
city: Chung-ju
country: Korea, Republic of
facility: Chungbook national University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwang-ju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan national University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The catholic univ. of korea Seoul ST. MARY's hospital
Study officials:
affiliation: Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea
name: Duk-Kyung Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang HJ, Song S, Chang SA, Kim HK, Jung HO, Choi JH, Lee JS, Kim KH, Jeong JO, Lee JH, Kim DK. Efficacy and Safety of Udenafil for the Treatment of Pulmonary Arterial Hypertension: a Placebo-controlled, Double-blind, Phase IIb Clinical Trial. Clin Ther. 2019 Aug;41(8):1499-1507. doi: 10.1016/j.clinthera.2019.05.006. Epub 2019 Jun 13.
citation: Chang SA, Kim HK, Chang HJ, Kim DK. Acute Hemodynamic Changes after Single Administration of Udenafil in Pulmonary Arterial Hypertension: a Phase IIa Study. Korean Circ J. 2019 Apr;49(4):353-360. doi: 10.4070/kcj.2018.0281. Epub 2018 Dec 10.