HealthyNCT05692869
A Study of Continuous Blood Pressure Monitoring in Healthy Participants
A study testing Propranolol, Pseudoephedrine and ABPM and Wearable Novel Devices in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propranolol, Pseudoephedrine and ABPM and Wearable Novel Devices
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Jan 2023to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Propranolol, Pseudoephedrine, ABPM and Wearable Novel Devices, No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Administered orally.
PseudoephedrineDrug
Administered orally.
ABPM and Wearable Novel DevicesDevice
ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.
No InterventionOther
No intervention during this period (Control Period)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Propranolol; Device: 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. Receives: Drug: Pseudoephedrine; Device: 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. Receives: Device: ABPM and Wearable Novel Devices; Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device
The Mean Change in SBP Using Chest Patch Device
Measured: Baseline through 48 hours
Secondary outcomes (6)
The Mean Change in SBP Using Wrist Device
The Mean Change in SBP Using Wrist Device
Measured: Baseline through 48 hours
The Mean Change in Diastolic Blood Pressure (DBP) Using Chest Patch Device and Wrist Device
The Mean Change in DBP Using Chest Patch Device and Wrist Device
Measured: Baseline through 48 hours
The Mean Change in SBP Using Chest Patch Device and Wrist Device
The Mean Change in SBP Using Chest Patch Device and Wrist Device
Measured: Baseline through 120 hours
The Mean Change in DBP Using Chest Patch Device and Wrist Device
The Mean Change in DBP Using Chest Patch Device and Wrist Device
Measured: Baseline through 120 hours
The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM)
The Mean Change in SBP Using Chest Patch Device, Wrist Device and ABPM
Measured: Baseline through 48 hours
The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM
The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM
Measured: Baseline through 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start31 Jan 2023
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692869
- Sponsor's protocol ID
- 18655
- Other IDs
- H6O-MC-O017
- Status last verified
- Apr 2023
- First submitted
- 12 Jan 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia)
- ClinicalTrials.gov ID
- NCT05692869
- Acronym / sponsor ID
- 18655
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABPM + Wearable Novel Devices + Propranolol | Experimental | Drug: Propranolol, Device: ABPM and Wearable Novel DevicesParticipants 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 | Experimental | Drug: Pseudoephedrine, Device: ABPM and Wearable Novel DevicesParticipants 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 | Experimental | Device: ABPM and Wearable Novel Devices, Other: No InterventionParticipants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAdministered orally. | Drug | ABPM + Wearable Novel Devices + Propranolol |
| PseudoephedrineAdministered orally. | Drug | ABPM + Wearable Novel Devices + Pseudoephedrine |
| ABPM and Wearable Novel DevicesABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial. | Device | ABPM + Wearable Novel Devices + Propranolol, ABPM + Wearable Novel Devices + Pseudoephedrine, ABPM + Wearable Novel Devices Only |
| No InterventionNo intervention during this period (Control Period) | Other | ABPM + Wearable Novel Devices Only |
Primary outcome
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
6 secondary outcomes
The Mean Change in SBP Using Wrist Device
Time frame: 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 SBP 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
Time frame: 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 DBP Using Chest Patch Device, Wrist Device and ABPM
Time frame: Baseline through 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol, Pseudoephedrine and ABPM and Wearable Novel Devices in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device (time frame: Baseline through 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.