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Combination Therapy

Quadruple Low-Dose Therapy for High Blood Pressure (QUARTET USA Trial)

Phase 2

Waitlist Available

Led By Mark D Huffman, PhD, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spanish or English speaker

Spanish or English speaker.

Must not have

Known contraindication to candesartan, amlodipine, indapamide or bisoprolol

Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR <50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of a low-dose quadruple combination therapy pill to standard dose monotherapy in patients with hypertension. The trial's primary hypothesis is that the quadruple combination therapy will lower blood pressure more effectively than standard dose monotherapy.

Who is the study for?

Adults over 18 with high blood pressure, documented within the last two years, who speak Spanish or English. Eligible participants may be untreated or on one blood pressure medication and must have specific blood pressure readings. Excluded are those unable to consent, with certain heart conditions, significant kidney issues, pregnant women not using contraception, and others deemed unsuitable by their physician.

What is being tested?

The trial is testing if a pill combining four different ultra-low-dose blood pressure medications works better for lowering blood pressure than standard single-drug therapy. Participants will be randomly assigned to receive either the combination pill (LDQT) or a standard dose of Candesartan.

What are the potential side effects?

Potential side effects could include typical reactions to blood pressure medications such as dizziness due to lowered blood pressure, headache, fatigue, possible allergic reactions to components in LDQT or Candesartan but specifics will depend on individual tolerances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English or Spanish.

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I speak English or Spanish.

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My blood pressure is within the specified ranges and I am either untreated or on one blood pressure medication.

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I am 18 years old or older.

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My blood pressure is high but not treated, or it's moderately high on one medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic or react badly to certain blood pressure medicines.

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I have high blood pressure due to another health issue, like kidney problems.

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I cannot follow the study's required procedures.

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I have had heart disease, stroke, or heart failure before.

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I am not pregnant, breastfeeding, and if of childbearing potential, I am using or plan to use contraception during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Mean Diastolic Blood Pressure

Change in Mean Systolic Blood Pressure

Health-related Quality of Life

+6 more

Other study objectives

Mean Change in Blood Urea Nitrogen

Mean Change in Serum Creatinine

Mean Change in Serum Potassium

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: QUARTET LDQTExperimental Treatment1 Intervention

Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

Group II: CandesartanActive Control1 Intervention

Patients randomized to the comparison arm will take a once daily 8mg candesartan.

0 / 10Eligibility criteria met