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Calcium Channel Blocker

Blood Pressure Management Strategies for High Blood Pressure

Phase 2
Recruiting
Led By Elaine Ku, MD MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-40 years of age
Diagnosis of hypertension or receiving anti-hypertensive therapy
Must not have
BP > 160/100 mmHg in clinic (stage II hypertension), regardless of whether patient is on therapy
Have cognitive impairment prohibiting participation in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial will test different ways to lower blood pressure, including medication and engagement strategies, to see what works best. Quality of life and adverse events will also be monitored.

Who is the study for?
This trial is for young adults aged 18-40 with high blood pressure, who are not pregnant, don't have severe hypertension or kidney issues, and aren't abusing substances. Participants should be stable (not marginally housed), able to follow the study protocol without cognitive impairments, and not involved in other trials that could affect their blood pressure.
What is being tested?
The trial tests three anti-hypertensive medications: Chlorthalidone, Amlodipine, and Losartan. It also examines three home BP monitoring methods: a cuffed device alone or combined with either a BP patch or watch. The goal is to see which combination best controls blood pressure while considering quality of life.
What are the potential side effects?
Possible side effects include dizziness, headache, fatigue from the medications; skin irritation from the BP patch; discomfort or allergic reactions from wearing devices like the cuff or watch.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.
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I have high blood pressure or am on medication for it.
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My blood pressure is often higher than 130/80 mmHg at the clinic and above 125/80 mmHg at home.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is above 160/100 mmHg.
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I do not have cognitive issues preventing me from joining the study.
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My kidney function is severely reduced.
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I am pregnant or planning to become pregnant and cannot take many blood pressure medicines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achieved systolic blood pressure
Secondary study objectives
Adherence to home BP monitoring

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

9Treatment groups
Experimental Treatment
Active Control
Group I: losartan 12.5 mg daily + home BP monitoring with watchExperimental Treatment2 Interventions
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
Group II: chlorthalidone 12.5 mg daily + home BP monitoring with watchExperimental Treatment2 Interventions
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
Group III: amlodipine 2.5 mg daily + home BP monitoring with watchExperimental Treatment2 Interventions
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
Group IV: amlodipine 2.5 mg daily + home BP monitoring with patchExperimental Treatment2 Interventions
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
Group V: Losartan 12.5 mg daily + home BP monitoring with patchExperimental Treatment2 Interventions
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
Group VI: Losartan 12.5 mg daily + home BP monitoring with cuffed deviceExperimental Treatment2 Interventions
Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring
Group VII: Chlorthalidone 12.5 mg daily + home BP monitoring with patchExperimental Treatment2 Interventions
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
Group VIII: Chlorthalidone 12.5 mg + Home BP monitoring with cuffed deviceExperimental Treatment2 Interventions
Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring
Group IX: Amlodipine 2.5 mg + Home BP monitoring with cuffed deviceActive Control2 Interventions
Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,056 Total Patients Enrolled
Elaine Ku, MD MASPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Amlodipine (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05370599 — Phase 2
High Blood Pressure Research Study Groups: amlodipine 2.5 mg daily + home BP monitoring with watch, Amlodipine 2.5 mg + Home BP monitoring with cuffed device, amlodipine 2.5 mg daily + home BP monitoring with patch, Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device, Chlorthalidone 12.5 mg daily + home BP monitoring with patch, Losartan 12.5 mg daily + home BP monitoring with cuffed device, Losartan 12.5 mg daily + home BP monitoring with patch, chlorthalidone 12.5 mg daily + home BP monitoring with watch, losartan 12.5 mg daily + home BP monitoring with watch
High Blood Pressure Clinical Trial 2023: Amlodipine Highlights & Side Effects. Trial Name: NCT05370599 — Phase 2
Amlodipine (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370599 — Phase 2
~17 spots leftby May 2025
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