A Study of Continuous Blood Pressure Monitoring in Healthy Participants

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Propranolol; Drug: Pseudoephedrine; Device: ABPM and Wearable Novel Devices; Other: No Intervention

• Registration Number: NCT05692869
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-20
• Study Start: 2023-01-31
• Status Verified: 2023-04
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Are overtly healthy males or females
• Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
• Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
• Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria

• 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
• Have history of sensitive skin or chronic skin conditions, like eczema
• Regular use of known drugs of abuse
• Are women who are pregnant or lactating
• Have known allergies to medications used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ABPM + Wearable Novel Devices + Pseudoephedrine	ABPM and Wearable Novel Devices	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.
ABPM + Wearable Novel Devices Only	ABPM and Wearable Novel Devices	Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.
ABPM + Wearable Novel Devices Only	No Intervention	Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.
ABPM + Wearable Novel Devices + Propranolol	ABPM and Wearable Novel Devices	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.
ABPM + Wearable Novel Devices + Propranolol	Propranolol	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.
ABPM + Wearable Novel Devices + Pseudoephedrine	Pseudoephedrine	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.

Primary Outcome Measures

Name	Time	Method
The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device	Baseline through 48 hours	The Mean Change in SBP Using Chest Patch Device

Secondary Outcome Measures

Name	Time	Method
The Mean Change in Diastolic Blood Pressure (DBP) Using Chest Patch Device and Wrist Device	Baseline through 48 hours	The Mean Change in DBP Using Chest Patch Device and Wrist Device
The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM)	Baseline through 48 hours	The Mean Change in SBP Using Chest Patch Device, Wrist Device and ABPM
The Mean Change in SBP Using Wrist Device	Baseline through 48 hours	The Mean Change in SBP Using Wrist Device
The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM	Baseline through 48 hours	The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM
The Mean Change in SBP Using Chest Patch Device and Wrist Device	Baseline through 120 hours	The Mean Change in SBP Using Chest Patch Device and Wrist Device
The Mean Change in DBP Using Chest Patch Device and Wrist Device	Baseline through 120 hours	The Mean Change in DBP Using Chest Patch Device and Wrist Device

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore