The Impact of Udenafil on Exercise Capacity in Severe Chr... | NCT01364181

Studies
The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01364181

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 20, 2011Estimated

Enrollment

23Actual

Phase

Phase 3

Conditions

Dyspnea
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension

Interventions

Udenafil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2011Actual

Completion Date

May 2011Actual

First Submitted Date

May 31, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2011

Last Update Posted Date

Jun 20, 2011Estimated

Name	Class
Dong-A PharmTech Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Study design

prospective, single arm, open-label study
Udenafil 50mg qd po for 8 weeks

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Udenafil	Experimental	Udenafil 50mg qd po	Drug: Udenafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Udenafil	Drug	Udenafil 50mg qd po	Udenafil	Zydena

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of 6-minute walk distance		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
change of mean pulmonary artery pressure	change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ho Il Yoon, M.D., Ph.D.	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22946546	Derived	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.

ID	Term
D004417	Dyspnea
D029424	Pulmonary Disease, Chronic Obstructive
D006976	Hypertension, Pulmonary
D009043	Motor Activity

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms