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OpenTrials
Completed

NCT Number: NCT05692869

A Study of Continuous Blood Pressure Monitoring in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol

Drug

Administered orally.

pseudoephedrine

Drug

Administered orally.

ABPM and Wearable Novel Devices

Device

ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.

No intervention

Other

No intervention during this period (Control Period)

Primary outcomes

  1. 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

Secondary outcomes

  1. The Mean Change in SBP Using Wrist Device

    Time frame: Baseline through 48 hours

    The Mean Change in SBP Using Wrist Device

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2023
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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