NCT01364181

Brief Summary

Pulmonary hypertension (PH) is a serious complication of COPD which is associated with shorter survival, more frequent exacerbation, and increased use of health resources. There is no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on exercise capacity of severe COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
Last Updated

June 20, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

May 31, 2011

Last Update Submit

June 17, 2011

Conditions

DyspneaChronic Obstructive Pulmonary DiseasePulmonary Hypertension

Keywords

UdenafilChronic obstructive pulmonary diseasepulmonary hypertensionPhosphodiesterase 5 inhibitorsExerciseDyspnea

Outcome Measures

Primary Outcomes (1)

  • change of 6-minute walk distance

    8 weeks

Secondary Outcomes (1)

  • change of mean pulmonary artery pressure

    8 weeks

Study Arms (1)

Udenafil

EXPERIMENTAL

Udenafil 50mg qd po

Drug: Udenafil

Interventions

UdenafilDRUG

Udenafil 50mg qd po

Also known as: Zydena
Udenafil

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value

You may not qualify if:

  • Acute exacerbation within 4 weeks of the study entry
  • Coronary heart disease
  • History of adverse event on PDE-5 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • Park JS, Lim HJ, Cho YJ, Lee JH, Yoon HI, Lee CT. Udenafil improves exercise capacity in patients with chronic obstructive pulmonary disease: a prospective study. COPD. 2012 Aug;9(5):499-504. doi: 10.3109/15412555.2012.694922. Epub 2012 Sep 4.

    PMID: 22946546DERIVED

MeSH Terms

Conditions

DyspneaPulmonary Disease, Chronic ObstructiveHypertension, PulmonaryMotor Activity

Interventions

udenafil

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesHypertensionVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Ho Il Yoon, M.D., Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

June 20, 2011

Record last verified: 2011-05

Locations

KR(1)