Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-31 @ 5:05 PM
Study NCT ID:
NCT00802893
Status:
TERMINATED
Last Update Posted:
2017-08-21
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092244', 'term': 'Isolated Systolic Hypertension'}], 'ancestors': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003402', 'term': 'sapropterin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'registerclinicaltrials@jhmi.edu', 'phone': '410-550-6484', 'title': 'Johns Hopkins University Clinical Trials Program', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Unknown. Due to difficulties recruiting, this study was terminated and no data was collected.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': '6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period\n\nOR\n\nPlacebo: placebo given BID for entire length of study', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': '6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period\n\nOR\n\nPlacebo: placebo given BID for entire length of study'}], 'timeFrame': '4-6 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to difficulties recruiting, this study was terminated and no data was collected.'}, {'type': 'SECONDARY', 'title': 'Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': '6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period\n\nOR\n\nPlacebo: placebo given BID for entire length of study'}], 'timeFrame': '4-8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to difficulties recruiting, this study was terminated and no data was collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': '6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period\n\nOR\n\nPlacebo: placebo given BID for entire length of study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': '6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period\n\nOR\n\nPlacebo: placebo given BID for entire length of study'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=40, years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'We were unable to recruit any subjects into this study so no subjects completed the protocol. Therefore, we are unable to provide any conclusions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2008-12-04', 'resultsFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-17', 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function', 'timeFrame': '4-6 weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness', 'timeFrame': '4-8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Isolated Systolic Hypertension with Endothelial Dysfunction'], 'conditions': ['Isolated Systolic Hypertension', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness.', 'detailedDescription': 'By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No change in prescribed antihypertension medications within the previous 30 days\n* Study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for FMD measurements\n* ISH with the following mean seated BP: SBP \\> 145 and \\< 180 mmHg. Diastolic blood pressure \\< 90mmHg\n\nExclusion Criteria:\n\n* Has known hypersensitivity to 6RBH4 or its excipients\n* Pregnant or breastfeeding at screening\n* Use of any investigational product or investigational medical device within 30 days prior to screening\n* Current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe GERD, GI ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure\n* Hypertension secondary to other medical conditions\n* Any severe comorbid condition that would limit life expectancy to \\<6 months\n* Current use of any nicotine containing substances\n* History of drug or alcohol abuse\n* MI, stroke or surgery within 90 days before Screening Visit\n* CABG within 6 months before the Screening Visit\n* Serum creatinine \\>2.0mg/dl or AST, ALT, GGT levels \\>2times upper limit of normal\n* Concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor\n* Previous treatment with any formulation of BH4'}, 'identificationModule': {'nctId': 'NCT00802893', 'briefTitle': 'Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel Study of Oral 6R-BH4 in Subjects With Isolated Systolic Hypertension and Endothelial Dysfunction', 'orgStudyIdInfo': {'id': 'NA_00014296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Drug', 'interventionNames': ['Drug: 6R-BH4']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '6R-BH4', 'type': 'DRUG', 'description': '6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period', 'armGroupLabels': ['Experimental Drug']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo given BID for entire length of study', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioMarin Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}