HypertensionPhase 3NCT03928145
Efficacy of Chlorthalidone and Hydrochlorothiazide Combined With Amiloride on Blood Pressure in Primary Hypertension.
A Phase 3 study testing Chlorthalidone 25 mg, Hydrochlorothiazide 50 mg and Amiloride 20 mg in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, safety profile and low cost, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Chlorthalidone 25 mg, Hydrochlorothiazide 50 mg and Amiloride 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Nov 2019to Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age 30 to 75 years).
- Diagnosis of primary hypertension based on ABPM (mean 24-h systolic BP ≥130 mmHg or mean 24-h diastolic BP ≥80 mmHg).
- No current use of antihypertensive medication.
Who cannot join
- Low life expectancy.
- Other indications for the use of diuretics.
- Intolerance or contraindications to the study drugs.
- Cardiovascular disease (heart failure, myocardial infarction or stroke).
- Secondary hypertension.
- Chronic kidney disease and / or abnormal renal function (creatinine >1.5 mg/dL).
Show all 12Show fewer
- Hyperkalemia (serum potassium >5.5 mEq/L).
- Gout.
- Previous antihypertensive treatment with more than one drug.
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg measured through office blood pressure.
- Pregnancy or prospective pregnancy during the study.
- Lactating women.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035 903
Flavio Fuchs, MD, PhD, +55 51 3359.8344, ffuchs@hcpa.edu.br
About this study
Official title: Efficacy of Chlorthalidone and Hydrochlorothiazide in Combination With Amiloride in Multiple Doses on Blood Pressure in Patients With Primary Hypertension: a Factorial Randomized Controlled Trial.
Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, safety profile and low cost, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Besides, concernments about adverse metabolic effects such as hypokalemia, hyperglycemia and hyperlipidemia do exist, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. In addition to control adverse effects of thiazides, amiloride could offer an additional blood pressure lowering effect, but the efficacy of different doses was not fully established. This study aims to investigate the blood pressure lowering efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension.
Read the detailed description
This is a factorial (2x2) randomized double-blinded clinical trial comparing the association of a thiazide diuretic (chlorthalidone 25 mg/day or hydrochlorothiazide 50 mg/day) with a potassium-sparing diuretic (amiloride 10 mg/day or amiloride 20 mg/day) as first drug option in patients aged 30 to 75 years with primary hypertension. The thiazide diuretic and amiloride will be combined in a single capsule. The capsules will be of the same size and color, so that neither the researcher nor the patients can distinguish the treatment by their appearance. The primary outcome will be the mean change from baseline in 24-h systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM). The secondary outcomes will be the mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ABPM, mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure, incidence of adverse events, variation of laboratory parameters and proportion of patients who achieved blood pressure control (<140/90 mmHg and <130/80 mmHg for office blood pressure and 24-h ABPM, respectively). The follow-up will last 12 weeks. For a P alpha of 0.05, power of 80%, and standard deviation of 9 mmHg, and absolute difference of 6 mmHg on systolic blood pressure on 24-h ABPM, it will be necessary to study a total of 76 patients. The sample size will be increased by 10% to compensate losses, resulting in 84 patients being randomized in total (42 for each arm).
- Conditions
- Hypertension
- Being tested
- Chlorthalidone 25 mg, Hydrochlorothiazide 50 mg, Amiloride 20 mg, Amiloride 10 mg
- Keywords
- Hypertension, Treatment, Chlorthalidone, Hydrochlorothiazide, Amiloride
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorthalidone 25 mgDrug
Also called Chlorthalidone
Chlorthalidone 25 mg taken orally in the morning for 12 weeks.
Hydrochlorothiazide 50 mgDrug
Also called Hydrochlorothiazide
Hydrochlorothiazide 50 mg taken orally in the morning for 12 weeks.
Amiloride 20 mgDrug
Also called Amiloride
Amiloride 20 mg taken orally in the morning for 12 weeks.
Amiloride 10 mgDrug
Also called Amiloride
Amiloride 10 mg taken orally in the morning for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chlorthalidone 25 mg + amiloride 20 mg | Experimental | Chlorthalidone 25 mg plus amiloride 20 mg combined in a single capsule, taken orally in the morning, for 12 weeks. Receives: Drug: Chlorthalidone 25 mg; Drug: Amiloride 20 mg |
| Chlorthalidone 25 mg + amiloride 10 mg | Active comparator | Chlorthalidone 25 mg plus amiloride 10 mg combined in a single capsule, taken orally in the morning, for 12 weeks. Receives: Drug: Chlorthalidone 25 mg; Drug: Amiloride 10 mg |
| Hydrochlorothiazide 50 mg + amiloride 20 mg | Active comparator | Hydrochlorothiazide 50 mg plus amiloride 20 mg combined in a single capsule, taken orally in the morning, for 12 weeks. Receives: Drug: Hydrochlorothiazide 50 mg; Drug: Amiloride 20 mg |
| Hydrochlorothiazide 50 mg + amiloride 10 mg | Active comparator | Hydrochlorothiazide 50 mg plus amiloride 10 mg combined in a single capsule, taken orally in the morning, for 12 weeks. Receives: Drug: Hydrochlorothiazide 50 mg; Drug: Amiloride 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in 24-h systolic blood pressure measured by ABPM.
Difference between the treatment arms in mean change from baseline in 24-h systolic blood pressure measured by ABPM.
Measured: 12 weeks
Mean change from baseline in 24-h diastolic blood pressure measured by ABPM.
Difference between the treatment arms in mean change from baseline in 24-h diastolic blood pressure measured by ABPM.
Measured: 12 weeks
Secondary outcomes (16)
Mean change from baseline in daytime and nighttime blood pressure measured by ABPM.
Difference between the treatment arms in mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ABPM.
Measured: 12 weeks
Mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure.
Difference between the treatment arms in mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure.
Measured: 12 weeks
Proportion of participants reporting adverse events.
Difference between treatment arms in the proportion of participants reporting adverse events.
Measured: 12 weeks
Mean change from baseline in total cholesterol.
Difference between the treatment arms in mean change from baseline in serum total cholesterol, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in HDL cholesterol (HDL-C).
Difference between the treatment arms in mean change from baseline in serum HDL cholesterol (HDL-C), measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in LDL cholesterol (LDL-C).
Difference between the treatment arms in mean change from baseline in serum LDL cholesterol (LDL-C), measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in triglycerides.
Difference between the treatment arms in mean change from baseline in serum triglycerides, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in creatinine.
Difference between the treatment arms in mean change from baseline in serum creatinine, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in urea.
Difference between the treatment arms in mean change from baseline in serum urea, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in potassium.
Difference between the treatment arms in mean change from baseline in serum potassium, measured in mEq/L.
Measured: 12 weeks
Mean change from baseline in sodium.
Difference between the treatment arms in mean change from baseline in serum sodium, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in magnesium.
Difference between the treatment arms in mean change from baseline in serum magnesium, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in uric acid.
Difference between the treatment arms in mean change from baseline in serum uric acid, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in fasting plasma glucose.
Difference between the treatment arms in mean change from baseline in fasting plasma glucose, measured in mg/dL.
Measured: 12 weeks
Mean change from baseline in hemoglobin A1c (HbA1c).
Difference between the treatment arms in mean change from baseline in hemoglobin A1c (HbA1c), measured in percentage.
Measured: 12 weeks
Proportion of participants achieving blood pressure control.
Difference between treatment arms in the proportion of participants achieving blood pressure control. Blood pressure control will be defined as <140/90 mmHg and <130/80 mmHg for office BP and 24-h ABPM, respectively.
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 posted25 Apr 2019
- Study start13 Nov 2019
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The trial has a factorial design, where participants will receive two simultaneous interventions: a thiazide diuretic (chlorthalidone 25 mg or hydrochlorothiazide 50 mg) and a potassium-sparing diuretic (amiloride 10 mg or amiloride 20 mg). Randomization will be done in 1:1:1:1 ratio, and participants will be randomly assigned to four groups: a) chlorthalidone 25 mg + amiloride 10 mg; b) chlorthalidone 25 mg + amiloride 20 mg; c) hydrochlorothiazide 50 mg + amiloride 10 mg; and d) hydrochlorothiazide 50 mg + amiloride 20 mg.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Cardiologia do Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Flavio Fuchs, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928145
- Sponsor's protocol ID
- 2016-0553
- Status last verified
- Dec 2019
- First submitted
- 22 Apr 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This trial is in accordance with the compliance of the reproducibility standards accordingly to the International Committee of Medical Journal Editors (ICMJE). The investigators intend to publish the results in an open-access journal, indexed at the Directory of Open Access Journals, with the copyrights transferred to the authors (CC By 4.0). Also, all materials, raw and treated data, statistical code and outputs will be publicly shared without restrictions to access the data neither expiration date. The repository was not chosen yet and will be provided in further amendments or in the final report of this study. All laboratory specimens, reports, data collection, process, and administrative forms will be identified by a coded identification number to maintain participant confidentiality. After full data analysis, all subject identifiers will be erased.
Publications
Bottino LG, Fuchs SC, Camilo BP, Rigo PR, Procianoy GS, Tavares AL, Valter LK, Soares RB, Martins VM, Fuchs FD. Comparative Effectiveness of Chlorthalidone Versus Hydrochlorothiazide and Dose-Response of Amiloride on Blood Pressure and Biochemical Parameters. J Am Heart Assoc. 2026 Aug 30:e047583. doi: 10.1161/JAHA.125.047583. Online ahead of print.
PubMed 42669885Martins VM, Helal L, Ferrari F, Bottino LG, Fuchs SC, Fuchs FD. Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial. Trials. 2019 Dec 16;20(1):736. doi: 10.1186/s13063-019-3909-z.
PubMed 31843024
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chlorthalidone and Hydrochlorothiazide in Combination With Amiloride in Multiple Doses on Blood Pressure in Patients With Primary Hypertension: a Factorial Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03928145
- Acronym / sponsor ID
- 2016-0553
- Conditions
- Hypertension
- Keywords
- Hypertension, Treatment, Chlorthalidone, Hydrochlorothiazide, Amiloride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Instituto de Cardiologia do Rio Grande do Sul
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 25 Apr 2019 (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.
Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, safety profile and low cost, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Besides, concernments about adverse metabolic effects such as hypokalemia, hyperglycemia and hyperlipidemia do exist, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. In addition to control adverse effects of thiazides, amiloride could offer an additional blood pressure lowering effect, but the efficacy of different doses was not fully established. This study aims to investigate the blood pressure lowering efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension.
Detailed description
This is a factorial (2x2) randomized double-blinded clinical trial comparing the association of a thiazide diuretic (chlorthalidone 25 mg/day or hydrochlorothiazide 50 mg/day) with a potassium-sparing diuretic (amiloride 10 mg/day or amiloride 20 mg/day) as first drug option in patients aged 30 to 75 years with primary hypertension. The thiazide diuretic and amiloride will be combined in a single capsule. The capsules will be of the same size and color, so that neither the researcher nor the patients can distinguish the treatment by their appearance. The primary outcome will be the mean change from baseline in 24-h systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM). The secondary outcomes will be the mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ABPM, mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure, incidence of adverse events, variation of laboratory parameters and proportion of patients who achieved blood pressure control (<140/90 mmHg and <130/80 mmHg for office blood pressure and 24-h ABPM, respectively). The follow-up will last 12 weeks. For a P alpha of 0.05, power of 80%, and standard deviation of 9 mmHg, and absolute difference of 6 mmHg on systolic blood pressure on 24-h ABPM, it will be necessary to study a total of 76 patients. The sample size will be increased by 10% to compensate losses, resulting in 84 patients being randomized in total (42 for each arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The trial has a factorial design, where participants will receive two simultaneous interventions: a thiazide diuretic (chlorthalidone 25 mg or hydrochlorothiazide 50 mg) and a potassium-sparing diuretic (amiloride 10 mg or amiloride 20 mg). Randomization will be done in 1:1:1:1 ratio, and participants will be randomly assigned to four groups: a) chlorthalidone 25 mg + amiloride 10 mg; b) chlorthalidone 25 mg + amiloride 20 mg; c) hydrochlorothiazide 50 mg + amiloride 10 mg; and d) hydrochlorothiazide 50 mg + amiloride 20 mg.
| Arm | Type | Receives |
|---|---|---|
| Chlorthalidone 25 mg + amiloride 20 mg | Experimental | Drug: Chlorthalidone 25 mg, Drug: Amiloride 20 mgChlorthalidone 25 mg plus amiloride 20 mg combined in a single capsule, taken orally in the morning, for 12 weeks. |
| Chlorthalidone 25 mg + amiloride 10 mg | Active comparator | Drug: Chlorthalidone 25 mg, Drug: Amiloride 10 mgChlorthalidone 25 mg plus amiloride 10 mg combined in a single capsule, taken orally in the morning, for 12 weeks. |
| Hydrochlorothiazide 50 mg + amiloride 20 mg | Active comparator | Drug: Hydrochlorothiazide 50 mg, Drug: Amiloride 20 mgHydrochlorothiazide 50 mg plus amiloride 20 mg combined in a single capsule, taken orally in the morning, for 12 weeks. |
| Hydrochlorothiazide 50 mg + amiloride 10 mg | Active comparator | Drug: Hydrochlorothiazide 50 mg, Drug: Amiloride 10 mgHydrochlorothiazide 50 mg plus amiloride 10 mg combined in a single capsule, taken orally in the morning, for 12 weeks. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age 30 to 75 years).
- Diagnosis of primary hypertension based on ABPM (mean 24-h systolic BP ≥130 mmHg or mean 24-h diastolic BP ≥80 mmHg).
- No current use of antihypertensive medication.
Key exclusion criteria (12 listed)
- Low life expectancy.
- Other indications for the use of diuretics.
- Intolerance or contraindications to the study drugs.
- Cardiovascular disease (heart failure, myocardial infarction or stroke).
- Secondary hypertension.
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 |
|---|---|---|
| Chlorthalidone 25 mgAlso: ChlorthalidoneChlorthalidone 25 mg taken orally in the morning for 12 weeks. | Drug | Chlorthalidone 25 mg + amiloride 10 mg, Chlorthalidone 25 mg + amiloride 20 mg |
| Hydrochlorothiazide 50 mgAlso: HydrochlorothiazideHydrochlorothiazide 50 mg taken orally in the morning for 12 weeks. | Drug | Hydrochlorothiazide 50 mg + amiloride 10 mg, Hydrochlorothiazide 50 mg + amiloride 20 mg |
| Amiloride 20 mgAlso: AmilorideAmiloride 20 mg taken orally in the morning for 12 weeks. | Drug | Chlorthalidone 25 mg + amiloride 20 mg, Hydrochlorothiazide 50 mg + amiloride 20 mg |
| Amiloride 10 mgAlso: AmilorideAmiloride 10 mg taken orally in the morning for 12 weeks. | Drug | Chlorthalidone 25 mg + amiloride 10 mg, Hydrochlorothiazide 50 mg + amiloride 10 mg |
Primary outcome
Mean change from baseline in 24-h systolic blood pressure measured by ABPM.
Time frame: 12 weeks
Difference between the treatment arms in mean change from baseline in 24-h systolic blood pressure measured by ABPM.
Mean change from baseline in 24-h diastolic blood pressure measured by ABPM.
Time frame: 12 weeks
Difference between the treatment arms in mean change from baseline in 24-h diastolic blood pressure measured by ABPM.
16 secondary outcomes
Mean change from baseline in daytime and nighttime blood pressure measured by ABPM.
Time frame: 12 weeks
Mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure.
Time frame: 12 weeks
Proportion of participants reporting adverse events.
Time frame: 12 weeks
Mean change from baseline in total cholesterol.
Time frame: 12 weeks
Mean change from baseline in HDL cholesterol (HDL-C).
Time frame: 12 weeks
Mean change from baseline in LDL cholesterol (LDL-C).
Time frame: 12 weeks
Mean change from baseline in triglycerides.
Time frame: 12 weeks
Mean change from baseline in creatinine.
Time frame: 12 weeks
Mean change from baseline in urea.
Time frame: 12 weeks
Mean change from baseline in potassium.
Time frame: 12 weeks
Mean change from baseline in sodium.
Time frame: 12 weeks
Mean change from baseline in magnesium.
Time frame: 12 weeks
Mean change from baseline in uric acid.
Time frame: 12 weeks
Mean change from baseline in fasting plasma glucose.
Time frame: 12 weeks
Mean change from baseline in hemoglobin A1c (HbA1c).
Time frame: 12 weeks
Proportion of participants achieving blood pressure control.
Time frame: 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 42669885Bottino LG, Fuchs SC, Camilo BP, Rigo PR, Procianoy GS, Tavares AL, Valter LK, Soares RB, Martins VM, Fuchs FD. Comparative Effectiveness of Chlorthalidone Versus Hydrochlorothiazide and Dose-Response of Amiloride on Blood Pressure and Biochemical Parameters. J Am Heart Assoc. 2026 Aug 30:e047583. doi: 10.1161/JAHA.125.047583. Online ahead of print.
- Derived from this study: PubMed 31843024Martins VM, Helal L, Ferrari F, Bottino LG, Fuchs SC, Fuchs FD. Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial. Trials. 2019 Dec 16;20(1):736. doi: 10.1186/s13063-019-3909-z.
- Individual participant dataSharing planned: Yes. This trial is in accordance with the compliance of the reproducibility standards accordingly to the International Committee of Medical Journal Editors (ICMJE). The investigators intend to publish the results in an open-access journal, indexed at the Directory of Open Access Journals, with the copyrights transferred to the authors (CC By 4.0). Also, all materials, raw and treated data, statistical code and outputs will be publicly shared without restrictions to access the data neither expiration date. The repository was not chosen yet and will be provided in further amendments or in the final report of this study. All laboratory specimens, reports, data collection, process, and administrative forms will be identified by a coded identification number to maintain participant confidentiality. After full data analysis, all subject identifiers will be erased.
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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.
Flavio Fuchs, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorthalidone 25 mg, Hydrochlorothiazide 50 mg and Amiloride 20 mg in people with Hypertension, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Dec 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavio Fuchs, MD, PhD (+55 51 3359.8344, ffuchs@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in 24-h systolic blood pressure measured by ABPM. (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?
On the ClinicalTrials.gov record for NCT03928145, which also lists 2 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 9 Dec 2019.