A Study of Continuous Blood Pressure Monitoring in Healthy Participants

April 12, 2023 updated by: Eli Lilly and Company

A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABPM + Wearable Novel Devices + 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.
Drug: Propranolol
Administered orally.
Device: ABPM and Wearable Novel Devices
ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.
Experimental: ABPM + Wearable Novel Devices + 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.
Device: ABPM and Wearable Novel Devices
ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.
Drug: Pseudoephedrine
Administered orally.
Experimental: ABPM + Wearable Novel Devices Only
Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.
Device: ABPM and Wearable Novel Devices
ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.
Other: No Intervention
No intervention during this period (Control Period)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device
Time Frame: Baseline through 48 hours
The Mean Change in SBP Using Chest Patch Device
Baseline through 48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18655
  • H6O-MC-O017 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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