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

Palo Alto (17 mi)

Overseen byMark D Huffman, PhD, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?To investigate, in a double-blind randomized controlled trial, whether initiating treatment with ultra-low-dose quadruple-combination therapy ("LDQT") will lower office blood pressure more effectively, and with fewer side effects, compared to initiating standard dose monotherapy as per current guidelines in patients with hypertension. Primary hypothesis: A combination pill comprising four types of blood pressure lowering medications, each at one-quarter standard doses, will lower office blood pressure more effectively than initiating patients with standard dose monotherapy as per contemporary clinical practice guideline recommendations.

Eligibility Criteria

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.

Inclusion Criteria

I speak English or Spanish.

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

I am 18 years old or older.

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

Exclusion Criteria

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

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

I cannot follow the study's required procedures.

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

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

Treatment Details

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.

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.