Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05692869
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2023-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Continuous Blood Pressure Monitoring in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D054199', 'term': 'Pseudoephedrine'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'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': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device', 'timeFrame': 'Baseline through 48 hours', 'description': 'The Mean Change in SBP Using Chest Patch Device'}], 'secondaryOutcomes': [{'measure': 'The Mean Change in SBP Using Wrist Device', 'timeFrame': 'Baseline through 48 hours', 'description': 'The Mean Change in SBP Using Wrist Device'}, {'measure': 'The Mean Change in Diastolic Blood Pressure (DBP) Using Chest Patch Device and Wrist Device', 'timeFrame': 'Baseline through 48 hours', 'description': 'The Mean Change in DBP Using Chest Patch Device and Wrist Device'}, {'measure': 'The Mean Change in SBP Using Chest Patch Device and Wrist Device', 'timeFrame': 'Baseline through 120 hours', 'description': 'The Mean Change in SBP Using Chest Patch Device and Wrist Device'}, {'measure': 'The Mean Change in DBP Using Chest Patch Device and Wrist Device', 'timeFrame': 'Baseline through 120 hours', 'description': 'The Mean Change in DBP Using Chest Patch Device and Wrist Device'}, {'measure': 'The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM)', 'timeFrame': 'Baseline through 48 hours', 'description': 'The Mean Change in SBP Using Chest Patch Device, Wrist Device and ABPM'}, {'measure': 'The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM', 'timeFrame': 'Baseline through 48 hours', 'description': 'The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study in healthy participants is to find out whether the traditional ambulatory blood pressure monitor (ABPM) and newer wearable devices (EmbracePlus smartwatch device, Biobeat chest patch device, and Aktiia wrist device) will accurately pick up changes in blood pressure caused by 2 different medications (propranolol and pseudoephedrine). The study will last about 29 days excluding the screening period of 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy males or females\n* Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening\n* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study\n* Have given written informed consent approved by Lilly and the ethical review board governing the site\n\nExclusion Criteria:\n\n* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study\n* Have history of sensitive skin or chronic skin conditions, like eczema\n* Regular use of known drugs of abuse\n* Are women who are pregnant or lactating\n* Have known allergies to medications used in the study'}, 'identificationModule': {'nctId': 'NCT05692869', 'briefTitle': 'A Study of Continuous Blood Pressure Monitoring in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia)', 'orgStudyIdInfo': {'id': '18655'}, 'secondaryIdInfos': [{'id': 'H6O-MC-O017', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABPM + Wearable Novel Devices + Propranolol', 'description': 'Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with propranolol administered orally for 5 days in one of three study periods.', 'interventionNames': ['Drug: Propranolol', 'Device: ABPM and Wearable Novel Devices']}, {'type': 'EXPERIMENTAL', 'label': 'ABPM + Wearable Novel Devices + Pseudoephedrine', 'description': 'Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with pseudoephedrine administered orally for 5 days in one of three study periods.', 'interventionNames': ['Drug: Pseudoephedrine', 'Device: ABPM and Wearable Novel Devices']}, {'type': 'EXPERIMENTAL', 'label': 'ABPM + Wearable Novel Devices Only', 'description': 'Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.', 'interventionNames': ['Device: ABPM and Wearable Novel Devices', 'Other: No Intervention']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['ABPM + Wearable Novel Devices + Propranolol']}, {'name': 'Pseudoephedrine', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['ABPM + Wearable Novel Devices + Pseudoephedrine']}, {'name': 'ABPM and Wearable Novel Devices', 'type': 'DEVICE', 'description': 'ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.', 'armGroupLabels': ['ABPM + Wearable Novel Devices + Propranolol', 'ABPM + Wearable Novel Devices + Pseudoephedrine', 'ABPM + Wearable Novel Devices Only']}, {'name': 'No Intervention', 'type': 'OTHER', 'description': 'No intervention during this period (Control Period)', 'armGroupLabels': ['ABPM + Wearable Novel Devices Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138623', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Lilly Centre for Clinical Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}