NCT05692869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

January 12, 2023

Last Update Submit

April 12, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device

    The Mean Change in SBP Using Chest Patch Device

    Baseline through 48 hours

Secondary Outcomes (6)

  • 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

    Baseline through 48 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

    Baseline through 120 hours

  • The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM)

    Baseline through 48 hours

  • +1 more secondary outcomes

Study Arms (3)

ABPM + Wearable Novel Devices + Propranolol

EXPERIMENTAL

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: PropranololDevice: ABPM and Wearable Novel Devices

ABPM + Wearable Novel Devices + Pseudoephedrine

EXPERIMENTAL

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.

Drug: PseudoephedrineDevice: ABPM and Wearable Novel Devices

ABPM + Wearable Novel Devices Only

EXPERIMENTAL

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 DevicesOther: No Intervention

Interventions

PropranololDRUG

Administered orally.

ABPM + Wearable Novel Devices + Propranolol
PseudoephedrineDRUG

Administered orally.

ABPM + Wearable Novel Devices + Pseudoephedrine
ABPM and Wearable Novel DevicesDEVICE

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

ABPM + Wearable Novel Devices + PropranololABPM + Wearable Novel Devices + PseudoephedrineABPM + Wearable Novel Devices Only
No InterventionOTHER

No intervention during this period (Control Period)

ABPM + Wearable Novel Devices Only

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

PropranololPseudoephedrine

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPhenethylaminesEthylamines

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 20, 2023

Study Start

January 31, 2023

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)