HypertensionPhase 2NCT05370599
Hypertension in Young Adults Trial
A Phase 2 study testing Anti-hypertensive agent: amlodipine, Anti-hypertensive agent: Chlorthalidone and Anti-hypertensive agent: Losartan in people with Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Anti-hypertensive agent: amlodipine, Anti-hypertensive agent: Chlorthalidone and Anti-hypertensive agent: Losartan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 7 Jan 2026
- Phase
- Phase 2
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age
- Diagnosis of hypertension or receiving anti-hypertensive therapy OR Has clinical BP readings >130/80 mmHg that would meet the definition of hypertension and have home BP readings >=125/80 mmHg
Who cannot join
- are or are planning to become pregnant, due to inability to take multiple classes of anti- hypertensive agents
- are marginally housed, due to concerns regarding routine follow-up
- are actively participating in a different interventional trial that may affect blood pressure
- are unwilling to consent to participate
- institutionalized individuals or prisoners
- are actively abusing illicit drugs or alcohol
Show all 12Show fewer
- have a history of poor or doubtful compliance (e.g., frequently missed appointments)
- have cognitive impairment prohibiting participation in the study
- History of allergy to any of the randomized medications
- Serum potassium >5.5 meq/L at the screening visit
- BP > 160/100 mmHg in clinic (stage II hypertension), regardless of whether patient is on therapy
- eGFR < 30 mL/min/1.73 m2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.
- Conditions
- Hypertension
- Being tested
- Anti-hypertensive agent: amlodipine, Anti-hypertensive agent: Chlorthalidone, Anti-hypertensive agent: Losartan, Home BP monitoring with cuffed device, Home BP monitoring with cuffed device + BP patch
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-hypertensive agent: amlodipineDrug
Patients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets.
Anti-hypertensive agent: ChlorthalidoneDrug
Patients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets.
Anti-hypertensive agent: LosartanDrug
Patients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets.
Home BP monitoring with cuffed deviceDevice
Patients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch.
Home BP monitoring with cuffed device + BP patchDevice
Patients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch.
Home BP monitoring with cuffed device + BP watchDevice
Patients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch.
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine 2.5 mg + Home BP monitoring with cuffed device | Active comparator | Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring Receives: Drug: Anti-hypertensive agent: amlodipine; Device: Home BP monitoring with cuffed device |
| Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device | Experimental | Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring Receives: Drug: Anti-hypertensive agent: Chlorthalidone; Device: Home BP monitoring with cuffed device |
| Losartan 12.5 mg daily + home BP monitoring with cuffed device | Experimental | Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring Receives: Drug: Anti-hypertensive agent: Losartan; Device: Home BP monitoring with cuffed device |
| amlodipine 2.5 mg daily + home BP monitoring with patch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring Receives: Drug: Anti-hypertensive agent: amlodipine; Device: Home BP monitoring with cuffed device + BP patch |
| Chlorthalidone 12.5 mg daily + home BP monitoring with patch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring Receives: Drug: Anti-hypertensive agent: Chlorthalidone; Device: Home BP monitoring with cuffed device + BP patch |
| Losartan 12.5 mg daily + home BP monitoring with patch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring Receives: Drug: Anti-hypertensive agent: Losartan; Device: Home BP monitoring with cuffed device + BP patch |
| amlodipine 2.5 mg daily + home BP monitoring with watch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring Receives: Drug: Anti-hypertensive agent: amlodipine; Device: Home BP monitoring with cuffed device + BP watch |
| chlorthalidone 12.5 mg daily + home BP monitoring with watch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring Receives: Drug: Anti-hypertensive agent: Chlorthalidone; Device: Home BP monitoring with cuffed device + BP watch |
| losartan 12.5 mg daily + home BP monitoring with watch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring Receives: Drug: Anti-hypertensive agent: Losartan; Device: Home BP monitoring with cuffed device + BP watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieved systolic blood pressure
Systolic blood pressure will be collected using at home cuffed devices. The readings at end of the pilot trial (or most recent readings available) will be used for analysis of the primary outcome.
Measured: Month 6
Secondary outcomes (1)
Adherence to home BP monitoring
Percent of weeks with at least 9 self-measured readings per week
Measured: Between month 0 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start15 Apr 2022
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Why it stopped: Funding limitations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 3x3 by BP agent and BP monitoring approach
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Ku, MD MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370599
- Sponsor's protocol ID
- 21-35626
- Status last verified
- Jan 2026
- First submitted
- 6 May 2022
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Johnson HM, Warner RC, Bartels CM, LaMantia JN. "They're younger... it's harder." Primary providers' perspectives on hypertension management in young adults: a multicenter qualitative study. BMC Res Notes. 2017 Jan 3;10(1):9. doi: 10.1186/s13104-016-2332-8.
PubMed 28057065
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension in Young Adults Trial
- ClinicalTrials.gov ID
- NCT05370599
- Acronym / sponsor ID
- 21-35626
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding limitations.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 11 May 2022 (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.
This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- 3x3 by BP agent and BP monitoring approach
| Arm | Type | Receives |
|---|---|---|
| Amlodipine 2.5 mg + Home BP monitoring with cuffed device | Active comparator | Drug: Anti-hypertensive agent: amlodipine, Device: Home BP monitoring with cuffed deviceUse of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring |
| Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device | Experimental | Drug: Anti-hypertensive agent: Chlorthalidone, Device: Home BP monitoring with cuffed deviceUse of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring |
| Losartan 12.5 mg daily + home BP monitoring with cuffed device | Experimental | Drug: Anti-hypertensive agent: Losartan, Device: Home BP monitoring with cuffed deviceUse of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring |
| amlodipine 2.5 mg daily + home BP monitoring with patch | Experimental | Drug: Anti-hypertensive agent: amlodipine, Device: Home BP monitoring with cuffed device + BP patchUse of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring |
| Chlorthalidone 12.5 mg daily + home BP monitoring with patch | Experimental | Drug: Anti-hypertensive agent: Chlorthalidone, Device: Home BP monitoring with cuffed device + BP patchUse of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring |
| Losartan 12.5 mg daily + home BP monitoring with patch | Experimental | Drug: Anti-hypertensive agent: Losartan, Device: Home BP monitoring with cuffed device + BP patchUse of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring |
| amlodipine 2.5 mg daily + home BP monitoring with watch | Experimental | Drug: Anti-hypertensive agent: amlodipine, Device: Home BP monitoring with cuffed device + BP watchUse of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring |
| chlorthalidone 12.5 mg daily + home BP monitoring with watch | Experimental | Drug: Anti-hypertensive agent: Chlorthalidone, Device: Home BP monitoring with cuffed device + BP watchUse of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring |
| losartan 12.5 mg daily + home BP monitoring with watch | Experimental | Drug: Anti-hypertensive agent: Losartan, Device: Home BP monitoring with cuffed device + BP watchUse of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 years of age
- Diagnosis of hypertension or receiving anti-hypertensive therapy OR Has clinical BP readings >130/80 mmHg that would meet the definition of hypertension and have home BP readings >=125/80 mmHg
Key exclusion criteria (12 listed)
- are or are planning to become pregnant, due to inability to take multiple classes of anti- hypertensive agents
- are marginally housed, due to concerns regarding routine follow-up
- are actively participating in a different interventional trial that may affect blood pressure
- are unwilling to consent to participate
- institutionalized individuals or prisoners
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 |
|---|---|---|
| Anti-hypertensive agent: amlodipinePatients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets. | Drug | Amlodipine 2.5 mg + Home BP monitoring with cuffed device, amlodipine 2.5 mg daily + home BP monitoring with patch, amlodipine 2.5 mg daily + home BP monitoring with watch |
| Anti-hypertensive agent: ChlorthalidonePatients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets. | Drug | Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device, Chlorthalidone 12.5 mg daily + home BP monitoring with patch, chlorthalidone 12.5 mg daily + home BP monitoring with watch |
| Anti-hypertensive agent: LosartanPatients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets. | Drug | Losartan 12.5 mg daily + home BP monitoring with cuffed device, Losartan 12.5 mg daily + home BP monitoring with patch, losartan 12.5 mg daily + home BP monitoring with watch |
| Home BP monitoring with cuffed devicePatients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch. | Device | Amlodipine 2.5 mg + Home BP monitoring with cuffed device, Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device, Losartan 12.5 mg daily + home BP monitoring with cuffed device |
| Home BP monitoring with cuffed device + BP patchPatients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch. | Device | Chlorthalidone 12.5 mg daily + home BP monitoring with patch, Losartan 12.5 mg daily + home BP monitoring with patch, amlodipine 2.5 mg daily + home BP monitoring with patch |
| Home BP monitoring with cuffed device + BP watchPatients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch. | Device | amlodipine 2.5 mg daily + home BP monitoring with watch, chlorthalidone 12.5 mg daily + home BP monitoring with watch, losartan 12.5 mg daily + home BP monitoring with watch |
Primary outcome
Achieved systolic blood pressure
Time frame: Month 6
Systolic blood pressure will be collected using at home cuffed devices. The readings at end of the pilot trial (or most recent readings available) will be used for analysis of the primary outcome.
1 secondary outcome
Adherence to home BP monitoring
Time frame: Between month 0 and 6
Results and safety
The study was stopped early (reason given: Funding limitations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 28057065Johnson HM, Warner RC, Bartels CM, LaMantia JN. "They're younger... it's harder." Primary providers' perspectives on hypertension management in young adults: a multicenter qualitative study. BMC Res Notes. 2017 Jan 3;10(1):9. doi: 10.1186/s13104-016-2332-8.
- 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.
Elaine Ku, MD MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-hypertensive agent: amlodipine, Anti-hypertensive agent: Chlorthalidone and Anti-hypertensive agent: Losartan in people with Hypertension, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Jan 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding limitations.). Results are not available in the source record.
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?
Achieved systolic blood pressure (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370599, which also lists 1 linked publication.
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 Jan 2026.