An Early Phase 1 interventional study of Losartan and Amlodipine in Hypertension and High Blood Pressure, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Columbia University · Early Phase 1, Interventional, and Treatment
Many patients want to know which blood pressure medication is the best for them. In this study, we will test the feasibility of a new approach to determining the best blood pressure medication for individual patients by performing an N-of-1 trial in which patients will have the opportunity to test a series of 3 blood pressure medications at escalating doses while carefully measuring their blood pressure and side-effects. At the end of each of these N-of-1 trials, we will ask patients to complete a questionnaire in which they rate their level of satisfaction with this approach to learning about which is the best blood pressure medication for them.
The goal of this research is to empower hypertensive patients to learn which blood pressure (BP) medication is best for them. Although lifestyle factors such as diet and exercise play an important role, medications may still needed to achieve BP control. Yet, there are substantial differences in the way BP medications affect patients; medications well-tolerated in some, cause severe side-effects in others. Similarly, medications that cause larger reductions in BP in some patients have smaller BP lowering effects in others. Despite this heterogeneity in treatment effects, there are no proven real-world methods to help patients identify the medication most suited to their needs.
One potential approach to individualizing BP treatment decisions is to conduct N-of-1 trials: a multiple crossover design conducted in a single patient. Despite the appeal of this approach, there are few published reports of BP medication N-of-1 trials. Therefore, the objective of this study is to determine the feasibility of conducting an N-of-1 BP medication trial in hypertensive patients. Patients who meet all the eligibility criteria will be asked to monitor their blood pressure and side-effects while taking a series of commonly prescribed blood pressure medications. If they are already taking a blood pressure medication, they will begin by tracking their blood pressure and side-effects while taking this medication for 1 week. They will then be asked to track their blood pressure and side-effects while taking a series of up to three other blood pressure medications (losartan - a renin-angiotensin system blocking agent, amlodipine - a calcium channel blocker, and hydrochlorothiazide - a thiazide diuretic). Each of these medications will be taken for 2 weeks at a time. The specific choice of medications and medication doses will be selected by the study physician. Unless patients have side-effects that lead them to discontinue a medication early, patients will be expected to take each medication at least twice in a balanced sequence (e.g., losartan - amlodipine - HCTZ - HCTZ - amlodipine - losartan). Patients will measure their blood pressure and medication side-effects during the 2nd week on each of these medications. Patients will have the option of escalating or decreasing dosages to identify the single medication/medication dose that best lowers their blood pressure with the least side-effects. Blood pressure will be measured using an Omron home blood pressure monitor. Side-effects will be tracked using a daily e-mailed survey that is completed over the Internet.
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This study's enrollment of 10 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
Patients with hypertension who are taking none or one BP medication will be will be provided with prescriptions for up to 3 BP medications representative of different BP medication classes (i.e., losartan, an angiotensin system blocking agent; amlodipine, a calcium channel blocker; and hydrochlorothiazide, a thiazide diuretic). Patients will be asked to take each medication for 2 weeks at a low dose, 2 weeks at a medium dose, and then 2 weeks at a high dose; provide health information and identify which medication they prefer to remain on following the N-of-1 trial (i.e., for long-term use).
Drug: Losartan · Drug: Amlodipine · Drug: Hydrochlorothiazide
An angiotensin II receptor antagonist drug used mainly to treat high blood pressure.
Also known as: Losartan potassium tablets, Cozaar
A calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension.
Also known as: Amlodipine besylate tablets, Norvasc
A diuretic medication often used to treat high blood pressure and swelling due to fluid build up.
Also known as: HCTZ, Hydrochlorothiazide tablets
Participants satisfied with participating in N-of-1 trial
Question assessing helpfulness of participating in N-of-1 trial methodology with respecting to managing their hypertension
Time frame: 4 months
Participants satisfied with blood pressure regimen
Treatment Satisfaction Questionnaire for Medication
Time frame: 5 months (or 1 month after completing N-of-1 trial)
Adherence to antihypertensive medication
Voils Nonadherence Measure
Time frame: 5 months (or 1 month after completing N-of-1 trial)
Plan to share: Undecided — IPD is currently presented in the manuscript due to the N-of-1 study design. Participant consent forms will be reviewed with the Columbia University IRB to determine whether we have permission to share de-identified IPD with other researchers.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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