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Combination Therapy

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

Phase 2
Waitlist Available
Led By Jody D Ciolino, PhD
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks
Awards & highlights

QUARTET USA Trial 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.Check my eligibility
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.See study design
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.

QUARTET USA Trial 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.

QUARTET USA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Mean Diastolic Blood Pressure
Change in Mean Systolic Blood Pressure
Health-related Quality of Life
+6 more
Other outcome measures
Mean Change in Blood Urea Nitrogen
Mean Change in Serum Creatinine
Mean Change in Serum Potassium
+4 more

QUARTET USA 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.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,169 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,932 Previous Clinical Trials
2,299,667 Total Patients Enrolled
ACCESS Community Health NetworkOTHER
6 Previous Clinical Trials
62,677 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies for prospective participants of this trial?

"As of now, this particular medical trial has stopped recruiting participants. It was first posted on August 30th 2019 and last updated on August 31st 2022, so it is not currently seeking enrolment. If you are looking for similar research studies, 746 trials concerning hypertension are presently enrolling patients while seven more related to QUARTET LDQT actively require volunteers."

Answered by AI

Has the FDA granted QUARTET LDQT approval for consumer consumption?

"Our team at Power has assigned QUARTET LDQT a rating of 2 on the safety scale; this is due to the fact that there are some data points suggesting its safety, but none verifying effectiveness."

Answered by AI

How many participants can enroll in this medical experiment?

"At this time, the study is not accepting any new applicants. The initial post was made on August 30th 2019 and last revised on August 31st 2022. If you're looking for other opportunities to participate in a medical trial, there are currently 746 trials related to hypertension and 7 studies associated with QUARTET LDQT actively searching for volunteers."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Illinois
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
ACCESS Martin T. Russo Family Health Center
Ashland Family Health Center

Why did patients apply to this trial?

I’ve been consistently getting high Blood Pressure readings.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
Mark Huffman 2019. "Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03640312.
All > High Blood Pressure
~11 spots leftby Apr 2025
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