Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-18 @ 2:07 AM
Study NCT ID:
NCT01690104
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2012-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of PXR Activation on Blood Pressure Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2012-09-07', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic ambulatory blood pressure', 'timeFrame': 'On day 8 of each arm', 'description': 'Systolic blood pressure measured with ambulatory blood pressure monitor.'}, {'measure': 'Diastolic ambulatory blood pressure', 'timeFrame': 'On day 8 of each arm', 'description': 'Diastolic blood pressure measured with ambulatory blood pressure monitor'}], 'secondaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'On day 9 of each arm'}, {'measure': 'Pulse (ambulatory)', 'timeFrame': 'On day 8 of each arm'}, {'measure': 'Plasma renin activity', 'timeFrame': 'On day 9 of each arm'}, {'measure': 'Serum aldosterone', 'timeFrame': 'On day 9 of each arm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rifampicin', 'pregnane X receptor', 'blood pressure'], 'conditions': ['Blood Pressure Regulation']}, 'referencesModule': {'references': [{'pmid': '35229613', 'type': 'DERIVED', 'citation': 'Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* BMI 19-30 kg/m2\n* Age 18-40 years\n* Systolic blood pressure 95 - 140 mmHg\n\nExclusion Criteria:\n\n* Any continuous medication\n* Any significant medical condition as judged by the study physician\n* Diastolic blood pressure over 90 mmHg\n* Sensitivity to rifampicin\n* Pregnancy and lactation\n* Difficult venipuncture\n* Abuse of alcohol or medications, or drug use.\n* Participation in other trial with medications in previous 30 days'}, 'identificationModule': {'nctId': 'NCT01690104', 'briefTitle': 'The Effect of PXR Activation on Blood Pressure Regulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'The Effect of PXR Activation on Blood Pressure Regulation', 'orgStudyIdInfo': {'id': 'Rifa-BP'}, 'secondaryIdInfos': [{'id': '2011-005522-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rifampicin', 'description': 'Rifampicin 600 mg daily', 'interventionNames': ['Drug: Rifampicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rifampicin', 'type': 'DRUG', 'otherNames': ['Rimapen'], 'armGroupLabels': ['Rifampicin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Janne Hukkanen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oulu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}