Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT00686803
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2008-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583022', 'term': 'PL-3994'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjordan@palatin.com', 'phone': '609.495.2200', 'title': 'Robert Jordan, Executive Director of Clinical Operations', 'organization': 'Palatin Technologies, Inc.'}, 'certainAgreement': {'otherDetails': 'PI was an employed by Palatin, as he was/is an employee of the CRO hired by Palatin to conduct the study. All confidentiality agreed upon between Palatin and the CRO applies.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PL-3994 0.1 µg/kg', 'description': 'PL-3994 0.1 µg/kg', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PL-3994 0.3 µg/kg', 'description': 'PL-3994 0.3 µg/kg', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'musculoskelatal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'depersonalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'urinary tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '4.8'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PL-3994 0.1 µg/kg', 'description': 'PL-3994 0.1 µg/kg'}, {'id': 'OG001', 'title': 'PL-3994 0.3 µg/kg', 'description': 'PL-3994 0.3 µg/kg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.366', 'spread': '0.0656', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach.\n\n•Maximum concentration (Cmax)\n\nThe subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacodynamics as Measured by cGMP Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PL-3994 0.1 µg/kg', 'description': 'PL-3994 0.1 µg/kg'}, {'id': 'OG001', 'title': 'PL-3994 0.3 µg/kg', 'description': 'PL-3994 0.3 µg/kg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.996', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.03'}, {'value': '1.435', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '4.26'}, {'value': '0.676', 'groupId': 'OG002', 'lowerLimit': '0.676', 'upperLimit': '0.676'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax\n\nThe patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PL-3994 0.1 µg/kg', 'description': 'PL-3994 0.1 µg/kg'}, {'id': 'FG001', 'title': 'PL-3994 0.3 µg/kg', 'description': 'PL-3994 0.3 µg/kg'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Initiation Date: 28 April 2008 Completion Date: 21 July 2008 Cohort 1: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo Cohort 2: 6 subjects: PL-3994 0.1 µg/kg; 1 subject Placebo Cohort 3: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo; Study stopped after Cohort 3.', 'preAssignmentDetails': 'Some results (i.e.Pharmacodynamic results) may include analyses only for the Evaluable Subjects population.The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK or PD parameters were possible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PL-3994 0.1 µg/kg', 'description': 'PL-3994 0.1 µg/kg'}, {'id': 'BG001', 'title': 'PL-3994 0.3 µg/kg', 'description': 'PL-3994 0.3 µg/kg'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '5.24', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '5.42', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '5.13', 'groupId': 'BG002'}, {'value': '53.3', 'spread': '5.72', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-08', 'studyFirstSubmitDate': '2008-05-27', 'resultsFirstSubmitDate': '2011-08-24', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-13', 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.', 'timeFrame': '24 hours', 'description': 'The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach.\n\n•Maximum concentration (Cmax)\n\nThe subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.'}, {'measure': 'Pharmacodynamics as Measured by cGMP Levels.', 'timeFrame': '24 hours', 'description': 'Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax\n\nThe patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'controlled hypertension', 'hypertensives'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.', 'detailedDescription': 'Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history\n* Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history.\n* Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg.\n\nExclusion Criteria:\n\n* Subject weight greater than 100 kg or less than 50 kg.\n* Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk.'}, 'identificationModule': {'nctId': 'NCT00686803', 'briefTitle': 'Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Palatin Technologies, Inc'}, 'officialTitle': 'A Single-Center, Single-Dose, Placebo-Controlled, Randomized, Double-Blind, Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension', 'orgStudyIdInfo': {'id': 'PL3994-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PL3994 Dose A', 'description': 'PL3994 Dose A', 'interventionNames': ['Drug: PL3994']}, {'type': 'EXPERIMENTAL', 'label': 'PL3994 Dose B', 'description': 'PL3994 Dose B', 'interventionNames': ['Drug: PL3994']}, {'type': 'EXPERIMENTAL', 'label': 'PL3994 Dose C', 'description': 'PL3994 Dose C', 'interventionNames': ['Drug: PL3994']}, {'type': 'EXPERIMENTAL', 'label': 'PL3994 Dose D', 'description': 'PL3994 Dose D', 'interventionNames': ['Drug: PL3994']}, {'type': 'EXPERIMENTAL', 'label': 'PL3994 Dose E', 'description': 'PL3994 Dose E', 'interventionNames': ['Drug: PL3994']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PL3994', 'type': 'DRUG', 'description': 'Study drug', 'armGroupLabels': ['PL3994 Dose A', 'PL3994 Dose B', 'PL3994 Dose C', 'PL3994 Dose D', 'PL3994 Dose E']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Steven Fischkoff, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Palatin Technologies, Inc'}, {'name': 'Robert Jordan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Palatin Technologies, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palatin Technologies, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}