Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H6O-MC-O017 | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change in SBP Using Wrist Device | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011433 | Propranolol |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
|
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 | 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 | 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) | 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 | The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM | Baseline through 48 hours |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |