HypertensionPhase 2QUARTET USANCT03640312
Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
A Phase 2 study testing QUARTET LDQT and Candesartan in people with Hypertension, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- QUARTET LDQT and Candesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2019to 31 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years)
- Spanish or English speaker.
- Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).
- Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.
- Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.
- Research grade blood pressure measurement (baseline mean) SBP>= 115 mmHg and DBP >= 60 mmHg
Who cannot join
- Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.
- Previous diagnosis of coronary artery disease, stroke, or heart failure.
- Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or >300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)
- 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).
- Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
- Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.
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- Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
- Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.
- Inability or unwillingness to provide written informed consent.
- Unable to complete study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ACCESS Martin T. Russo Family Health Center
Bloomingdale, Illinois, 60108
Ashland Family Health Center
Chicago, Illinois, 60609
About this study
Official title: A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA)
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.
Read the detailed description
This trial will investigate whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT; including candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) will lower automated office blood pressure and 24-hour ambulatory blood pressure at 12 weeks more effectively, and with no increase in side effects, compared to initiating standard dose monotherapy (candesartan 8 mg) in adults with raised blood pressure (SBP>130 mmHg or DBP>80 mmHg) and without cardiovascular disease. Our preliminary data from a short-term (4-week) crossover trial of 18 participants suggest that LDQT lowers office blood pressure by 22/13 mmHg on average compared with placebo with no difference in serious adverse events. Effects on 24-hour ambulatory blood pressure were similar.
The investigators will perform this phase II, single site, randomized controlled trial in a network of federally qualified health centers in Chicago because this population bears a disproportionate burden of blood pressure related diseases, and the investigators have previously successfully conducted clinical studies in this population.
While the investigators hypothesize this intervention will be easily implemented and efficacious for all patients and clinicians, the investigators will explore variation in treatment effect by potential moderating variables, including age, sex, race/ethnicity, and health literacy level. Beyond examining efficacy, the investigators also plan to assess feasibility of implementing this intervention in a clinical setting by simultaneously evaluating implementation outcomes of acceptability, preferences, and lessons of LDQT among patients and clinicians.
- Conditions
- Hypertension
- Being tested
- QUARTET LDQT, Candesartan
- Keywords
- Hypertension, Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUARTET LDQTDrug
Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
CandesartanDrug
Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| QUARTET LDQT | Experimental | 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. Receives: Drug: QUARTET LDQT |
| Candesartan | Active comparator | Patients randomized to the comparison arm will take a once daily 8mg candesartan. Receives: Drug: Candesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Systolic Blood Pressure
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
Measured: 12 weeks
Secondary outcomes (9)
Mean Systolic Blood Pressure
Mean automated office systolic blood pressure adjusted for baseline values.
Measured: 6 weeks
Change in Mean Diastolic Blood Pressure
Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values.
Measured: 6 weeks
Mean Diastolic Blood Pressure
Mean automated office diastolic blood pressure adjusted for baseline values.
Measured: 6 weeks
Proportion of Patients With Hypertension Control
Proportion of patients with hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg).
Measured: 6 and 12 weeks
Number of Patients Requiring Step up Treatment
Number of patients requiring step-up treatment.
Measured: 6 weeks
Proportion of Patients With Adverse Event Free Hypertension Control
Proportion of patients with adverse event free hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg).
Measured: 12 weeks
Medication Adherence
Medication adherence defined by objective pill counts
Measured: 12 weeks
Health-related Quality of Life
Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline.
Measured: 12 weeks
Change in Mean Systolic Blood Pressure
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start30 Aug 2019
- Primary completion31 May 2022
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ACCESS Community Health Network, University of Sydney
- Responsible party
- Principal investigator, Mark Huffman, Washington University School of Medicine
- Investigators
- Mark D Huffman, PhD, MD, Principal investigator, Northwestern UniversityJody D Ciolino, PhD, Principal investigator, Overall Study Officials:
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640312
- Sponsor's protocol ID
- 202203097-STU00205834
- Acronym
- QUARTET USA
- Status last verified
- Dec 2024
- First submitted
- 15 Aug 2018
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared through NHLBI BioLINCC.
Publications
Huffman MD, Baldridge AS, Lazar D, Abbas H, Mejia J, Flowers FM, Quintana A, Jackson A, Kandula NR, Lloyd-Jones DM, Persell SD, Khan SS, Paparello JJ, Chopra A, Tripathi P, Vu MH, Chow CK, Ciolino JD. Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial. Hypertens Res. 2024 Jun;47(6):1668-1677. doi: 10.1038/s41440-024-01658-y. Epub 2024 Apr 8.
PubMed 38584159Sanuade OA, Jacobson TA, Quintana A, Flowers FM, Abbasi H, Vu MH, Baldridge AS, Mejia J, Lazar D, Ciolino JD, Huffman MD, Kandula NR. Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA). J Am Heart Assoc. 2024 Jan 2;13(1):e032236. doi: 10.1161/JAHA.123.032236. Epub 2023 Dec 29.
PubMed 38156601Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.
PubMed 36116516
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA)
- ClinicalTrials.gov ID
- NCT03640312
- Acronym / sponsor ID
- QUARTET USA / 202203097-STU00205834
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- ACCESS Community Health Network, University of Sydney
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 22 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial will investigate whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT; including candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) will lower automated office blood pressure and 24-hour ambulatory blood pressure at 12 weeks more effectively, and with no increase in side effects, compared to initiating standard dose monotherapy (candesartan 8 mg) in adults with raised blood pressure (SBP>130 mmHg or DBP>80 mmHg) and without cardiovascular disease. Our preliminary data from a short-term (4-week) crossover trial of 18 participants suggest that LDQT lowers office blood pressure by 22/13 mmHg on average compared with placebo with no difference in serious adverse events. Effects on 24-hour ambulatory blood pressure were similar.
The investigators will perform this phase II, single site, randomized controlled trial in a network of federally qualified health centers in Chicago because this population bears a disproportionate burden of blood pressure related diseases, and the investigators have previously successfully conducted clinical studies in this population.
While the investigators hypothesize this intervention will be easily implemented and efficacious for all patients and clinicians, the investigators will explore variation in treatment effect by potential moderating variables, including age, sex, race/ethnicity, and health literacy level. Beyond examining efficacy, the investigators also plan to assess feasibility of implementing this intervention in a clinical setting by simultaneously evaluating implementation outcomes of acceptability, preferences, and lessons of LDQT among patients and clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QUARTET LDQT | Experimental | Drug: QUARTET LDQTPatients 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. |
| Candesartan | Active comparator | Drug: CandesartanPatients randomized to the comparison arm will take a once daily 8mg candesartan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥18 years)
- Spanish or English speaker.
- Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).
- Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.
- Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.
Key exclusion criteria (10 listed)
- Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.
- Previous diagnosis of coronary artery disease, stroke, or heart failure.
- Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or >300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)
- 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).
- Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUARTET LDQTUltra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. | Drug | QUARTET LDQT |
| CandesartanStandard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. | Drug | Candesartan |
Primary outcome
Change in Mean Systolic Blood Pressure
Time frame: 12 weeks
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
9 secondary outcomes
Mean Systolic Blood Pressure
Time frame: 6 weeks
Change in Mean Diastolic Blood Pressure
Time frame: 6 weeks
Mean Diastolic Blood Pressure
Time frame: 6 weeks
Proportion of Patients With Hypertension Control
Time frame: 6 and 12 weeks
Number of Patients Requiring Step up Treatment
Time frame: 6 weeks
Proportion of Patients With Adverse Event Free Hypertension Control
Time frame: 12 weeks
Medication Adherence
Time frame: 12 weeks
Health-related Quality of Life
Time frame: 12 weeks
Change in Mean Systolic Blood Pressure
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38584159Huffman MD, Baldridge AS, Lazar D, Abbas H, Mejia J, Flowers FM, Quintana A, Jackson A, Kandula NR, Lloyd-Jones DM, Persell SD, Khan SS, Paparello JJ, Chopra A, Tripathi P, Vu MH, Chow CK, Ciolino JD. Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial. Hypertens Res. 2024 Jun;47(6):1668-1677. doi: 10.1038/s41440-024-01658-y. Epub 2024 Apr 8.
- Derived from this study: PubMed 38156601Sanuade OA, Jacobson TA, Quintana A, Flowers FM, Abbasi H, Vu MH, Baldridge AS, Mejia J, Lazar D, Ciolino JD, Huffman MD, Kandula NR. Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA). J Am Heart Assoc. 2024 Jan 2;13(1):e032236. doi: 10.1161/JAHA.123.032236. Epub 2023 Dec 29.
- Derived from this study: PubMed 36116516Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared through NHLBI BioLINCC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Huffman, PhD, MD principal investigator
Northwestern University
Jody D Ciolino, PhD principal investigator
Overall Study Officials:
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QUARTET LDQT and Candesartan in people with Hypertension, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Systolic Blood Pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640312, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.