Apparent Resistant HypertensionFastControlNCT07259733
Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)
A study testing Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine) in people with Apparent Resistant Hypertension and Hypertension, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial summary
This is a single-center, open-label, randomized clinical trial conducted at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. The study evaluates a simplified treatment strategy for patients with apparent resistant hypertension, comparing fixed triple combination therapy (perindopril, indapamide, and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Apparent Resistant Hypertension, Hypertension, High Blood Pressure
- What is being tested?
- Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment with 3 to 5 classes of antihypertensive drugs, including a maximum dose of an ACE inhibitor or ARB, a thiazide or thiazide-like diuretic, and a calcium channel blocker (CCB);
- Recent 24-hour ambulatory blood pressure monitoring (ABPM) (<1 month) showing values above target (24-hour BP ≥130/80 mmHg);
- Office blood pressure ≥140/90 mmHg;
- Poor adherence to treatment, defined as a score ≥1 point on the Morisky Medication Adherence Scale (MMAS-4).
- -
- Exclusion Criteria:Secondary hypertension (including hyperaldosteronism, pheochromocytoma, or renovascular hypertension);
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- History of intolerance or adverse reactions to study medications, such as ACE inhibitors (cough or angioedema), thiazide or thiazide-like diuretics (electrolyte disturbances), or calcium channel blockers (significant ankle edema or headache);
- Indispensable use of beta-blockers or mineralocorticoid receptor antagonists;
- Office blood pressure ≥ 220 × 120 mmHg;
- Reduced left ventricular ejection fraction (LVEF < 55%);
- Severe renal impairment (creatinine clearance < 30 mL/min or eGFR < 30 mL/min/1.73 m²);
- Atrial fibrillation or atrial flutter;
- Use of oral anticoagulants;
- Significant valvular heart disease;
- Body mass index (BMI) ≥ 40 kg/m²;
- Pregnant or breastfeeding women;
- Severe psychiatric disorders;
- Active malignancy with life expectancy < 2 years;
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012909
About this study
Official title: Strategy for Rapid Control of Apparent Resistant Arterial Hypertension in the Public Health System (FAST Control)
This is a single-center, open-label, randomized clinical trial conducted at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. The study evaluates a simplified treatment strategy for patients with apparent resistant hypertension, comparing fixed triple combination therapy (perindopril, indapamide, and amlodipine) with usual care using multiple separate antihypertensive drugs. The primary objective is to compare 24-hour blood pressure control as measured by ABPM at 12 weeks between the two treatment strategies. Enrollment began on July 15, 2023, and this study was registered retrospectively.
Read the detailed description
Resistant hypertension remains a major clinical challenge, frequently resulting from therapeutic inertia, poor adherence, and the complexity of multi-drug regimens. Simplified treatment strategies, such as fixed-dose combinations, have been proposed to improve adherence and blood pressure control.
The FAST Control study is a single-center, open-label, randomized (1:1), parallel-group clinical trial designed to compare the efficacy of a simplified treatment strategy versus usual care in patients with apparent resistant hypertension (aRHTN). The simplified treatment consists of a fixed triple combination of perindopril 10 mg, indapamide 2.5 mg, and amlodipine 10 mg once daily, while the usual care group maintains their current regimen with up to five antihypertensive drug classes administered as separate tablets.
Eligible participants are adults aged 18 to 75 years, followed at the Hypertension Section of the Instituto Dante Pazzanese de Cardiologia (São Paulo, Brazil), presenting with uncontrolled blood pressure despite treatment with 3-5 drug classes (including a renin-angiotensin system blocker, a thiazide or thiazide-like diuretic, and a long-acting calcium channel blocker). Apparent resistant hypertension is confirmed by 24-hour ambulatory blood pressure monitoring (ABPM) showing a mean BP ≥130/80 mmHg. Participants with secondary hypertension, severe comorbidities, or contraindications to the study medications are excluded.
The primary objective is to compare the rate of 24-hour blood pressure control as measured by ABPM at 12 weeks between the simplified treatment and usual care groups. Secondary objectives include evaluating the difference in absolute reduction of 24-hour blood pressure (BP), as measured by ABP between the two groups; comparing the office blood pressure control rate after 12 weeks between the groups; assessing the difference in absolute reduction of office blood pressure between the groups; and comparing the number of antihypertensive drug classes and the total number of pills used between the groups throughout the study.
This study was approved by the Research Ethics Committee of the Instituto Dante Pazzanese de Cardiologia (CAAE [56042422900005462]) and registered retrospectively, as patient enrollment began on July 15, 2023.
- Being tested
- Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine), Usual Care Antihypertensive Regimen
- Keywords
- Apparent resistant hypertension; Fixed-dose combination; Triple combination therapy; Perindoprile; Indapamide; Amlodipine; Clinical Trial; Brazil
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)Drug
Participants receive a fixed-dose tablet containing perindopril 10 mg, indapamide 2.5 mg, and amlodipine 10 mg administered once daily for 12 weeks. Randomized participants in this group discontinue their previous antihypertensive medications and replace them with the single-pill triple fixed-dose combination. Treatment adjustments may be made if required according to office blood pressure measurements
Usual Care Antihypertensive RegimenDrug
Participants continue their usual antihypertensive therapy, consisting of up to five drug classes administered as separate tablets. Medication types and doses are adjusted by the investigator as needed to achieve office blood pressure control, following standard clinical practice. Treatment modifications are permitted throughout the 12-week study period according to clinical judgment and blood pressure response.
| Study group | Role | What they receive |
|---|---|---|
| Simplified Fixed-Dose Triple Combination | Experimental | Randomized participants in this group discontinue their previous antihypertensive medications and replace them with the single-pill triple fixed-dose combination. Treatment adjustments may be made if required according to office blood pressure measurements. Receives: Drug: Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine) |
| Usual Care Antihypertensive Regimen | Active comparator | Participants continue their usual antihypertensive treatment regimen, consisting of up to five drug classes administered as separate tablets, for 12 weeks, with medication adjustments performed as needed according to office blood pressure measurements. Receives: Drug: Usual Care Antihypertensive Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of 24-hour Blood Pressure Control Measured by ABPM at 12 weeks
Proportion of participants achieving 24-hour mean blood pressure <130/80 mmHg, as measured by ambulatory blood pressure monitoring (ABPM), after 12 weeks of treatment.
Measured: 12 weeks
Rate of 24-hour Blood Pressure Control Measured by Ambulatory Blood Pressure Monitoring (ABPM) at 12 weeks
Proportion of participants achieving 24-hour mean blood pressure <130/80 mmHg, as measured by ambulatory blood pressure monitoring (ABPM), after 12 weeks of treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start15 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apparent Resistant HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to receive either a simplified fixed-dose triple combination (perindopril 10 mg/indapamide 2.5 mg/amlodipine 10 mg once daily) or usual care with their current individualized antihypertensive regimen (up to five drug classes). Each group follows its assigned treatment throughout the 12-week study period.
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Principal investigator, Fabrizio Urbinati Maroja, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259733
- Sponsor's protocol ID
- 56042422900005462
- Acronym
- FastControl
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the primary and secondary outcome measures will be shared after de-identification. Data will be available upon reasonable request to qualified researchers for purposes of verification or secondary analysis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Rapid Control of Apparent Resistant Arterial Hypertension in the Public Health System (FAST Control)
- ClinicalTrials.gov ID
- NCT07259733
- Acronym / sponsor ID
- FastControl / 56042422900005462
- Keywords
- Apparent resistant hypertension; Fixed-dose combination; Triple combination therapy; Perindoprile; Indapamide; Amlodipine; Clinical Trial; Brazil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, randomized clinical trial conducted at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. The study evaluates a simplified treatment strategy for patients with apparent resistant hypertension, comparing fixed triple combination therapy (perindopril, indapamide, and amlodipine) with usual care using multiple separate antihypertensive drugs. The primary objective is to compare 24-hour blood pressure control as measured by ABPM at 12 weeks between the two treatment strategies. Enrollment began on July 15, 2023, and this study was registered retrospectively.
Detailed description
Resistant hypertension remains a major clinical challenge, frequently resulting from therapeutic inertia, poor adherence, and the complexity of multi-drug regimens. Simplified treatment strategies, such as fixed-dose combinations, have been proposed to improve adherence and blood pressure control.
The FAST Control study is a single-center, open-label, randomized (1:1), parallel-group clinical trial designed to compare the efficacy of a simplified treatment strategy versus usual care in patients with apparent resistant hypertension (aRHTN). The simplified treatment consists of a fixed triple combination of perindopril 10 mg, indapamide 2.5 mg, and amlodipine 10 mg once daily, while the usual care group maintains their current regimen with up to five antihypertensive drug classes administered as separate tablets.
Eligible participants are adults aged 18 to 75 years, followed at the Hypertension Section of the Instituto Dante Pazzanese de Cardiologia (São Paulo, Brazil), presenting with uncontrolled blood pressure despite treatment with 3-5 drug classes (including a renin-angiotensin system blocker, a thiazide or thiazide-like diuretic, and a long-acting calcium channel blocker). Apparent resistant hypertension is confirmed by 24-hour ambulatory blood pressure monitoring (ABPM) showing a mean BP ≥130/80 mmHg. Participants with secondary hypertension, severe comorbidities, or contraindications to the study medications are excluded.
The primary objective is to compare the rate of 24-hour blood pressure control as measured by ABPM at 12 weeks between the simplified treatment and usual care groups. Secondary objectives include evaluating the difference in absolute reduction of 24-hour blood pressure (BP), as measured by ABP between the two groups; comparing the office blood pressure control rate after 12 weeks between the groups; assessing the difference in absolute reduction of office blood pressure between the groups; and comparing the number of antihypertensive drug classes and the total number of pills used between the groups throughout the study.
This study was approved by the Research Ethics Committee of the Instituto Dante Pazzanese de Cardiologia (CAAE [56042422900005462]) and registered retrospectively, as patient enrollment began on July 15, 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to receive either a simplified fixed-dose triple combination (perindopril 10 mg/indapamide 2.5 mg/amlodipine 10 mg once daily) or usual care with their current individualized antihypertensive regimen (up to five drug classes). Each group follows its assigned treatment throughout the 12-week study period.
| Arm | Type | Receives |
|---|---|---|
| Simplified Fixed-Dose Triple Combination | Experimental | Drug: Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)Randomized participants in this group discontinue their previous antihypertensive medications and replace them with the single-pill triple fixed-dose combination. Treatment adjustments may be made if required according to office blood pressure measurements. |
| Usual Care Antihypertensive Regimen | Active comparator | Drug: Usual Care Antihypertensive RegimenParticipants continue their usual antihypertensive treatment regimen, consisting of up to five drug classes administered as separate tablets, for 12 weeks, with medication adjustments performed as needed according to office blood pressure measurements. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Treatment with 3 to 5 classes of antihypertensive drugs, including a maximum dose of an ACE inhibitor or ARB, a thiazide or thiazide-like diuretic, and a calcium channel blocker (CCB);
- Recent 24-hour ambulatory blood pressure monitoring (ABPM) (<1 month) showing values above target (24-hour BP ≥130/80 mmHg);
- Office blood pressure ≥140/90 mmHg;
- Poor adherence to treatment, defined as a score ≥1 point on the Morisky Medication Adherence Scale (MMAS-4).
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)Participants receive a fixed-dose tablet containing perindopril 10 mg, indapamide 2.5 mg, and amlodipine 10 mg administered once daily for 12 weeks. Randomized participants in this group discontinue their previous antihypertensive medications and replace them with the single-pill triple fixed-dose combination. Treatment adjustments may be made if required according to office blood pressure measurements | Drug | Simplified Fixed-Dose Triple Combination |
| Usual Care Antihypertensive RegimenParticipants continue their usual antihypertensive therapy, consisting of up to five drug classes administered as separate tablets. Medication types and doses are adjusted by the investigator as needed to achieve office blood pressure control, following standard clinical practice. Treatment modifications are permitted throughout the 12-week study period according to clinical judgment and blood pressure response. | Drug | Usual Care Antihypertensive Regimen |
Primary outcome
Rate of 24-hour Blood Pressure Control Measured by ABPM at 12 weeks
Time frame: 12 weeks
Proportion of participants achieving 24-hour mean blood pressure <130/80 mmHg, as measured by ambulatory blood pressure monitoring (ABPM), after 12 weeks of treatment.
Rate of 24-hour Blood Pressure Control Measured by Ambulatory Blood Pressure Monitoring (ABPM) at 12 weeks
Time frame: 12 weeks
Proportion of participants achieving 24-hour mean blood pressure <130/80 mmHg, as measured by ambulatory blood pressure monitoring (ABPM), after 12 weeks of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the primary and secondary outcome measures will be shared after de-identification. Data will be available upon reasonable request to qualified researchers for purposes of verification or secondary analysis.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine) in people with Apparent Resistant Hypertension and Hypertension, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
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 19 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio G Laurinavicius, MD, PhD (5511996695389, antonio.laurinavicius@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 24-hour Blood Pressure Control Measured by ABPM at 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.