Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT01172756
Status:
TERMINATED
Last Update Posted:
2014-11-04
First Post:
2010-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542595', 'term': 'riociguat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-03', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-29', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary artery mean pressure at rest', 'timeFrame': 'Peak change from baseline within 6 hours after a single dose of study drug'}], 'secondaryOutcomes': [{'measure': 'Adverse event collection', 'timeFrame': 'until 30 days after study drug treatment'}, {'measure': 'Plasma concentrations to obtain pharmacokinetic profile of Riociguat', 'timeFrame': 'Within 24 hours after study drug treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Left ventricular dysfunction'], 'conditions': ['Hypertension, Pulmonary', 'Ventricular Dysfunction, Left']}, 'referencesModule': {'references': [{'pmid': '24991733', 'type': 'DERIVED', 'citation': 'Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for information of Bayer products for Europe'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction\n\nExclusion Criteria:\n\n* Types of pulmonary hypertension other than group 2.2 of Dana Point Classification'}, 'identificationModule': {'nctId': 'NCT01172756', 'acronym': 'DILATE', 'briefTitle': 'A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts', 'orgStudyIdInfo': {'id': '14554'}, 'secondaryIdInfos': [{'id': '2010-018436-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Riociguat (BAY63-2521)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Riociguat (BAY63-2521)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'interventionNames': ['Drug: Riociguat (BAY63-2521)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 4', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Riociguat (BAY63-2521)', 'type': 'DRUG', 'description': '0.5 mg single oral dose', 'armGroupLabels': ['Arm 1']}, {'name': 'Riociguat (BAY63-2521)', 'type': 'DRUG', 'description': '1 mg single oral dose', 'armGroupLabels': ['Arm 2']}, {'name': 'Riociguat (BAY63-2521)', 'type': 'DRUG', 'description': '2 mg single oral dose', 'armGroupLabels': ['Arm 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8020', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4010', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '50924', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}