Evaluation of fixed combination strategies with three drugs in low/moderate doses versus two drugs in moderate/high doses for blood pressure control

Randomized trial to evaluate fixed combination strategies with three drugs at low/moderate doses versus two drugs at moderate/high doses and their action on peripheral and central blood pressure parameters, arterial stiffness and endothelial function

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-5p9w6vz

Enrollment

Unknown

Registered

2025-08-18

Start date

2024-08-14

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antihypertensive Agents

Interventions

This is a phase four, prospective, national, multicenter, single blind, randomized controlled clinical study with one-to-one, open allocation, with blinded evaluation of clinical outcomes. Central ran

D03.383.725.203.065

D02.886.590.700.135.261.476

D03.383.129.308.674

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient over 18 years of age; both sexes; hypertension being treated with a double combination of antihypertensive drugs and Systolic Blood Pressure - SBP greater than 140 mmHg or Diastolic Blood Pressure - DBP greater than 90mmHg

Exclusion criteria

Exclusion criteria: Any clinical observation finding (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to participation in the clinical trial or presence of uncontrolled chronic disease(s); history of alcohol or illicit drug use disorder in the last 2 years; women of childbearing potential who are not using a reliable contraceptive method or who are pregnant, breastfeeding or planning to become pregnant; known allergy or hypersensitivity to the components of the drugs used during the clinical trial; known renal insufficiency, with estimated Glomerular Filtration Rate - GFR persistently lower than 30 mL/min/1.73 m2 - by the CKD-EPI equation; participation in clinical trial protocols in the last 12 (twelve) months, unless the investigator judges that there may be a direct benefit to them; known allergy or hypersensitivity to the components of the drugs used during the clinical trial

Design outcomes

Primary

Measure	Time frame
To assess whether the triple combination strategy at low/moderate doses is more effective than the double combination at moderate/high doses in controlling peripheral and central blood pressure, arterial stiffness and endothelial function. Effectiveness will be measured by the mean reduction in peripheral and central blood pressure (mmHg), improvement in arterial stiffness indices and increase in endothelial function assessed by flow-mediated dilation, comparing data before the start of treatment and at the end of the study (ninety days plus or minus four days).	—

Measure

Time frame

To assess whether the triple combination strategy at low/moderate doses is more effective than the double combination at moderate/high doses in controlling peripheral and central blood pressure, arterial stiffness and endothelial function. Effectiveness will be measured by the mean reduction in peripheral and central blood pressure (mmHg), improvement in arterial stiffness indices and increase in endothelial function assessed by flow-mediated dilation, comparing data before the start of treatment and at the end of the study (ninety days plus or minus four days).

—

Secondary

Measure	Time frame
To assess whether the triple combination in low/moderate doses is more effective than the double combination in medium/high doses in the following aspects: reduction in peripheral blood pressure (mmHg) over the course of the study, reduction in central blood pressure (mmHg) over the course of the study, changes in arterial stiffness as measured by specific parameters (e.g. pulse wave velocity), maintenance of endothelial function as assessed by flow-mediated dilation in a subgroup of patients. Data will be collected and analyzed by comparing measurements taken at the selection visit and at the end of the study.	—

Measure

Time frame

To assess whether the triple combination in low/moderate doses is more effective than the double combination in medium/high doses in the following aspects: reduction in peripheral blood pressure (mmHg) over the course of the study, reduction in central blood pressure (mmHg) over the course of the study, changes in arterial stiffness as measured by specific parameters (e.g. pulse wave velocity), maintenance of endothelial function as assessed by flow-mediated dilation in a subgroup of patients. Data will be collected and analyzed by comparing measurements taken at the selection visit and at the end of the study.

—

Countries

Brazil

Contacts

Public ContactWeimar de Souza

Faculdade de Medicina da Universidade Federal de Goiás

sebbabarroso@gmail.com+55 (62) 99416-4280

Outcome results

None listed

Source: REBEC (via WHO ICTRP)