Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-08 @ 8:33 PM
Study NCT ID:
NCT00679705
Status:
COMPLETED
Last Update Posted:
2009-04-20
First Post:
2008-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012312', 'term': 'Ritodrine'}, {'id': 'C047046', 'term': 'atosiban'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-17', 'studyFirstSubmitDate': '2008-05-15', 'studyFirstSubmitQcDate': '2008-05-16', 'lastUpdatePostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.', 'timeFrame': '240 minutes'}], 'secondaryOutcomes': [{'measure': 'Effect of the specific dosing levels of the medications on the level of arterial stiffness', 'timeFrame': '240 minutes'}, {'measure': 'Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure', 'timeFrame': '240 minutes'}, {'measure': 'Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall', 'timeFrame': '240 minutes'}, {'measure': 'Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance', 'timeFrame': '240 minutes'}, {'measure': 'Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure', 'timeFrame': '240 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodynamics and arterial function of healthy females'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'This trial will consist of two parts:\n\nA pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the design of the final study.\n\nThe final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 and 40 years old;\n* In good health, especially no cardiovascular diseases, obstructive lung diseases, chronic kidney diseases or diabetes mellitus.\n* Using a proper anticonception method (orally, subcutaneously);\n* A negative pregnancy test.\n\nExclusion Criteria:\n\n* Intolerance of Ritodrine;\n* On chronic medication, except oral and subcutaneous contraception\n* History or present presentation of cardiac arrythmias;\n* Risk of being pregnant or less than 6 months postpartum;\n* Giving breastfeeding;\n* Previous uteral surgery;\n* Using an intra-uteral device (IUD);\n* A severe addiction: nicotine (\\> 10 cigarettes/day), alcohol (\\> 3 units/day), caffeine (\\> 5 units/day) or any extralegally drugs.'}, 'identificationModule': {'nctId': 'NCT00679705', 'briefTitle': 'Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Pilot Study: A Dose-Response Finding Study of Ritodrine (Pre-Par®) to Find the Highest Well Tolerated Dose in Young, Healthy, Female Volunteers. To Find the Size-Order of the Hemodynamical Effects of Ritodrine (PrePar®) and Atosiban (Tractocile®) to Determine the Relevance of a PK/PD-Modelling in the Final Study. Final Study: Investigating the Influence of Tocolytical Medications: Ritodrine (PrePar®) and Atosiban (Tractocile®) at the Clinical Dose on the Hemodynamics and Arterial Function in Healthy Female Volunteers, Compared to Placebo During Continuous Intravenous Infusion.', 'orgStudyIdInfo': {'id': '2008/110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Ritodrine (Pre-Par)', 'interventionNames': ['Drug: Ritodrine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Atosiban (Tractocile)', 'interventionNames': ['Drug: Atosiban']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ritodrine', 'type': 'DRUG', 'description': 'Ritodrine (Pre-Par), maximum 400 µg/minute, IV', 'armGroupLabels': ['1']}, {'name': 'Atosiban', 'type': 'DRUG', 'description': 'Atosiban (Tractocile), maximum 300 µg/minute, IV', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Glucose 5%, IV', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Luc Van Bortel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Luc Van Bortel, MD, PhD', 'oldOrganization': 'University Hospital Ghent'}}}}