NCT01553721

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

3.6 years

First QC Date

January 1, 2012

Last Update Submit

April 15, 2016

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

  • Phase IIa - Pulmonary vascular resistance index(PVRI)

    4 hours

  • Phase IIb - 6-minute walk distance

    16weeks

Study Arms (2)

udenafil

EXPERIMENTAL

1. Phase IIa Experimental : Udenafil Dose 1, Dose 2 2. Phase IIb Experimental : Udenafil

Drug: udenafil

placebo

PLACEBO COMPARATOR

1. Phase IIa Placebo Comparator : Placebo 2. Phase IIb Placebo Comparator : Placebo

Drug: placebo

Interventions

udenafilDRUG

Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID)

udenafil
placeboDRUG

Phase IIa - placebo Phase IIb - placebo

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Seoul National University Hospital

Seoul, Chongno-gu, 28 Yongon-dong, 110-744, South Korea

Location

Samsung Medical Center

Seoul, Gangnam-Gu, Irwon-Dong 50, 135-710, South Korea

Location

Severance Hospital, Yonsei University Health System

Special City of Seoul, Seodaemungu, 250 Seonsanno, 120-752, South Korea

Location

Chungbook national University Hospital

Chungju, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Pusan national University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

The catholic univ. of korea Seoul ST. MARY's hospital

Seoul, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 31202506DERIVED

  • 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.

    PMID: 30808080DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

udenafil

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Duk-Kyung Kim, M.D., Ph.D

    Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2012

First Posted

March 14, 2012

Study Start

August 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

KR(9)