Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-04 @ 5:45 PM
Study NCT ID:
NCT00482235
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2007-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2007-06-01', 'studyFirstSubmitQcDate': '2007-06-01', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '19135348', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* You are between the ages of 40 and 75\n* You have had a history for at least a year of COPD symptoms\n* You have a history of smoking one pack of cigarettes per day for 10 years\n\nExclusion Criteria:\n\n* You have been in a research study with an investigational drug or vaccine in the last 4 weeks.\n* You have donated blood in the last 4 weeks.\n* You have been hospitalized or had major surgery in the last 4 weeks\n* You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms\n* You have a history of heart problems in the last 6 months\n* You have a history of stomach problems\n* You are unwilling to avoid grapefruit juice throughout the study'}, 'identificationModule': {'nctId': 'NCT00482235', 'briefTitle': 'A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'orgStudyIdInfo': {'id': '0359-016'}, 'secondaryIdInfos': [{'id': '2007_569'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0359', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}