Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-31 @ 3:05 AM
Study NCT ID:
NCT01067859
Status:
TERMINATED
Last Update Posted:
2015-10-08
First Post:
2010-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Sponsor:
Organization:
Raw JSON
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'2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2010-02-11', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2010-02-11', 'dispFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Capillary Wedge Pressure', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'Cardiac index (CI)', 'timeFrame': '8 hours and 48 hours'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Follow up (after 30+5 days)'}, {'measure': 'Right atrial pressure (RAP)', 'timeFrame': '8 hours and 48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure'], 'conditions': ['Acute Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and non-pregnant, non-lactating female subjects, age \\>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy\n* Subjects must have the clinical diagnosis of Congestive Heart Failure (CHF) made at least three months prior to enrollment\n* Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:\n\n * dyspnea and\n * clinical evidence of volume overload\n\nExclusion Criteria:\n\n* Acute de-novo heart failure\n* Acute myocardial infarction and/or myocardial infarction within 30 days\n* Valvular heart disease requiring surgical intervention during the course of the study\n* Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease\n* Primary hypertrophic cardiomyopathy\n* Acute inflammatory heart disease, eg, acute myocarditis\n* Unstable angina requiring angiography'}, 'identificationModule': {'nctId': 'NCT01067859', 'acronym': 'COMPOSE 2', 'briefTitle': 'A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)', 'orgStudyIdInfo': {'id': '14663'}, 'secondaryIdInfos': [{'id': '2009-014378-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Cinaciguat (BAY58-2667)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Cinaciguat (BAY58-2667)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cinaciguat (BAY58-2667)', 'type': 'DRUG', 'description': 'Infusion of 25 µg/h during 48 hours', 'armGroupLabels': ['Arm 1']}, {'name': 'Cinaciguat (BAY58-2667)', 'type': 'DRUG', 'description': 'Infusion of 10 µg/h during 48 hours', 'armGroupLabels': ['Arm 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Infusion of placebo during 48 hours', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45267-0542', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': 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