A Study of MK0359 in Patients With Chronic Obstructive Pu... | NCT00482235

Studies
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)

NCT00482235

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Dec 2, 2015Estimated

Enrollment

45Actual

Phase

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

MK0359

Countries

Not provided

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

ID	Type	Description	Link
2007_569

Status Module

Record Verification Date

Nov 2015

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

Dec 2002

Primary Completion Date

Apr 2003Actual

Completion Date

Apr 2003Actual

First Submitted Date

Jun 1, 2007

First Submission Date that Met QC Criteria

Jun 1, 2007

First Posted Date

Jun 5, 2007Estimated

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

Nov 30, 2015

Last Update Posted Date

Dec 2, 2015Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Name	Type	Description	Arm Group Labels	Other Names
MK0359	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

You are between the ages of 40 and 75
You have had a history for at least a year of COPD symptoms
You have a history of smoking one pack of cigarettes per day for 10 years

Exclusion Criteria:

You have been in a research study with an investigational drug or vaccine in the last 4 weeks.
You have donated blood in the last 4 weeks.
You have been hospitalized or had major surgery in the last 4 weeks
You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms
You have a history of heart problems in the last 6 months
You have a history of stomach problems
You are unwilling to avoid grapefruit juice throughout the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19135348	Result	Lu S, Liu N, Dass SB, Reiss TF, Knorr BA. Randomized, placebo-controlled study of a selective PDE4 inhibitor in the treatment of asthma. Respir Med. 2009 Mar;103(3):342-7. doi: 10.1016/j.rmed.2008.10.024. Epub 2009 Jan 8.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease