NCT03640312CompletedPhase 2
Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA)
Source: ClinicalTrials.gov · Last updated 3 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 15 Aug 2018
- Start date
- 30 Aug 2019
- Primary completion date
- 31 May 2022
- Lead sponsor
- Washington University School of Medicine
- Diseases
- High blood pressure
- NCT number
- NCT03640312
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 62
- From 30 Aug 2019 to the primary completion date, 31 May 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of coronary artery disease, stroke, or heart failure.
- 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.
- 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.
Lab values
- 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).
Other
- Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.
- 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).
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ACCESS Martin T. Russo Family Health Center Coordinator of this site? Confirm its status | Bloomingdale | United States | Unknown status |
| Ashland Family Health Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.