Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00874120
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The sponsor reserves all publication and presentation rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Intent-to-treat population. Participants who received at least one dose of study medication were included in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Phenylephrine', 'description': 'Phenylephrine HCL Extended Release tablets 30 mg twice daily for 7 days', 'otherNumAtRisk': 114, 'otherNumAffected': 0, 'seriousNumAtRisk': 114, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo twice daily for 7 days', 'otherNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenylephrine', 'description': 'Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '118.3', 'spread': '9.24', 'groupId': 'OG000'}, {'value': '118.6', 'spread': '9.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5480', 'groupIds': ['OG000', 'OG001'], 'paramType': 'residual error term from the ANOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '1.1', 'pValueComment': 'P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 hours after final dose of each 7-day treatment period.', 'description': 'Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol population included 100 participants who completed both treatment periods and have 24-hour Ambulatory Blood Pressure Monitoring (ABPM) data for SBP measurements for each study drug, 46 participants who received phenylephrine followed by placebo and 54 participants who received placebo followed by phenylephrine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phenylephrine Followed by Placebo', 'description': 'Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days'}, {'id': 'FG001', 'title': 'Placebo Followed by Phenylephrine', 'description': 'Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'positive drug test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash-out Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phenylephrine Followed by Placebo', 'description': 'Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days'}, {'id': 'BG001', 'title': 'Placebo Followed by Phenylephrine', 'description': 'Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '10.14', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '10.99', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '10.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'dispFirstSubmitDate': '2010-02-05', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2009-04-01', 'dispFirstSubmitQcDate': '2010-02-05', 'resultsFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2009-04-01', 'dispFirstPostDateStruct': {'date': '2010-03-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-02', 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).', 'timeFrame': '24 hours after final dose of each 7-day treatment period.', 'description': 'Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Pressure', 'Human Experimentation']}, 'descriptionModule': {'briefSummary': 'Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory blood pressure measurement will be performed beginning on Day 7 of each treatment period following administration of the study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy, male or female volunteers must be 18 years or older, with a Body Mass Index (BMI) between 19-30 inclusive \\[BMI = weight (kilograms)/height (meters squared)\\].\n* Clinical laboratory tests (complete blood count, blood chemistries, urinalysis), Human Immunodeficiency Virus (HIV) antibodies, hepatitis B surface antigen, hepatitis C antibody must be within normal limits or clinically acceptable to the Investigator/Sponsor.\n* Drug screen for drugs and alcohol with a high potential for abuse must be negative at screening.\n* Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures or participation.\n* Subjects must agree not to take a monoamine oxidase inhibitor (MAOI) for two weeks (14 days) prior to study participation and for two weeks (14 days) after the end of their study participation.\n* Subjects must have normal or clinically acceptable physical exam and Electrocardiogram (ECG) intervals (PR, QRS, QT and QTc) on 12-lead ECG (recorded at 25 millimeters/second \\[mm/s\\]).\n* Subjects must have a mean after 5 minute of rest sitting systolic/diastolic office blood pressure ≤ 138/88 millimeters of mercury (mmHg).\n* Subjects with controlled diabetes prior to entry must have a mean sitting after 5 minute of rest systolic/diastolic office blood pressure ≤ 128/78 mmHg from non-dominated arm\n* Females must have the urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1 of Period 1.\n* Female subjects of childbearing potential must be using medically acceptable birth control measures.\n* Subjects must understand the dosing schedule.\n* Subjects must be able to read and write in English.\n\nExclusion Criteria:\n\n* Subjects must not have any significant medical condition which, in the judgment of the Investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include hyperthyroidism, hypothyroidism, uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.\n* Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration.\n* Subjects who have received an investigational drug within 30 days prior to study dosing.\n* Subjects who are, appear to be, or are known, current or former drug addicts or alcoholics.\n* Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody.\n* Subjects who are positive for HIV antibodies.\n* Subjects who have a clinically significant history of food or drug allergy.\n* Subjects who have a known allergy or intolerance to phenylephrine HCl.\n* Females who are pregnant, nursing or unwilling to use/practice adequate contraception (hormonal, Intrauterine Device, barrier method, etc.).\n* Subjects taking topical or oral decongestant products within 7 days of Visit 2.\n* Subjects taking antihypertensive medication.\n* Subjects taking monoamine oxidase inhibitors.\n* Subjects taking tricyclic antidepressants (e.g. amitriptyline, nortriptyline, imipramine)\n* Subjects taking antithyroid medication (e.g. propylthiouracil, methimazole, iodides)."}, 'identificationModule': {'nctId': 'NCT00874120', 'briefTitle': 'Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Randomized, Placebo-Controlled, Double-Blind, Two-Way Crossover Study to Evaluate the Effects of Phenylephrine HCl Extended-Release Tablets 30 mg Compared to Placebo on Ambulatory Blood Pressure', 'orgStudyIdInfo': {'id': '18121'}, 'secondaryIdInfos': [{'id': 'CL2007-07'}, {'id': 'P07529', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenylephrine HCl Extended-Release tablets 30 mg', 'description': 'Phenylephrine HCl Extended Release tablets 30 mg', 'interventionNames': ['Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg', 'type': 'DRUG', 'description': 'Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.', 'armGroupLabels': ['Phenylephrine HCl Extended-Release tablets 30 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo taken twice daily (12 hours apart) for 7 days.', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}