Arterial HypertensionPhase 3CARDNCT01191450

Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension

A Phase 3 study testing Chlorthalidone 25 mg + amiloride hydrochloride 5 mg and Higroton® Laboratório Novartis in people with Arterial Hypertension, run by Eurofarma Laboratorios S.A. at 10 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Arterial Hypertension
What is being tested?: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg and Higroton® Laboratório Novartis
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 246 participants
Where: 10 sitesBrazil
Study dates: Aug 2011to Aug 2013
Phase: Phase 3
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Systolic blood pressure between 140 mmHg - 159 mmHg
Diastolic blood pressure between 90 mmHg - 99 mmHg
Subject aged ≥ 60 years old
Be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project.
Diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration.

Who cannot join

Any serious or severe clinically significant medical condition.
Psychiatric or neurological diseases
A condition that, as per Principal Investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient.
Participation in any other investigational study within 12 months prior to Visit 1.
Known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study
Routine prior use of diuretics

Show all 14Show fewer

Oral anticoagulant use
Fast glycemia > 150 mg/dL
Medical treatment, not related to study, scheduled for the clinical trial duration; except non-serious, controlled comorbidities in current medical follow-up.
Expected onset of additional antihypertensive drug after the study onset
Acute myocardial infarction within last 6 months
Prior decompensated coronary artery disease
Known thyroid, renal or liver dysfunction, at investigator's discretion
Obesity - body mass index (BMI) > 33 kg/m2

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Brazil10 sites

UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP
Botucatu, São Paulo
Centro de Estudos de Diabetes e Hipertensão
Fortaleza, Ceará
Liga de Hipertensão Arterial - Universidade Federal de Goiás
Goiânia, Goiás
Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares
São José do Rio Preto, São Paulo
Clínica Paulista de Doenças Cardiovasculares - FGM
São Paulo
Hospital Santa Marcelina
São Paulo
Hospital São Camilo
São Paulo
IMA - Instituto de Medicina Avançada
São Paulo
Instituto de Moléstias Cardiovasculares de Tatuí
Tatuí, São Paulo
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
Vitória, Espírito Santo

Other trials in Brazil

About this study

Official title: A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension

The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.

Read the detailed description

To assess the efficacy and safety of the association of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Diupress® Eurofarma) in the treatment of elderly patients with arterial hypertension, compared to Chlorthalidone 25mg (Higroton® Laboratório Novartis) in same presentation form.

Some eligibility criteria:

perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram

Conditions: Arterial Hypertension
Being tested: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg, Higroton® Laboratório Novartis
Keywords: chlortalidone, amiloride, arterial hypertension
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 mg + amiloride hydrochloride 5 mgDrug
Also called Diupress® (Eurofarma Laboratórios Ltda.)
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
Higroton® Laboratório NovartisDrug
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks

Study groups in NCT01191450
Study group	Role	What they receive
Higroton®	Active comparator	Chlorthalidone 25mg - one oral tablet a day in the morning Receives: Drug: Higroton® Laboratório Novartis
Diupress®	Experimental	Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning Receives: Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
Measured: Visit 4 (75 ± 3 days of V1)

Secondary outcomes (1)

Blood Pressure
Will be considered as secondary outcomes BP <140 X 90 mmHg after Visit 4 (75 ± 3 days of V1).
V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
Measured: Visit 4 (75 ± 3 days of V1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Aug 2013

First posted30 Aug 2010 (estimated)
Study startAug 2011
Primary completionAug 2013
Study completionAug 2013

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.
Other trials for Arterial 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01191450
Sponsor's protocol ID: EF 114
Acronym: CARD
Status last verified: Mar 2025
First submitted: 26 Aug 2010
Last updated: 12 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension
ClinicalTrials.gov ID: NCT01191450
Acronym / sponsor ID: CARD / EF 114
Conditions: Arterial Hypertension
Keywords: chlortalidone, amiloride, arterial hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 30 Aug 2010 (estimated)
Results: Posted 12 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.

Detailed description

Some eligibility criteria:

perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Higroton®	Active comparator	Drug: Higroton® Laboratório NovartisChlorthalidone 25mg - one oral tablet a day in the morning
Diupress®	Experimental	Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mgChlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Systolic blood pressure between 140 mmHg - 159 mmHg
Diastolic blood pressure between 90 mmHg - 99 mmHg
Subject aged ≥ 60 years old
Be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project.
Diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration.

Key exclusion criteria (14 listed)

Any serious or severe clinically significant medical condition.
Psychiatric or neurological diseases
A condition that, as per Principal Investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient.
Participation in any other investigational study within 12 months prior to Visit 1.
Known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study

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 mg + amiloride hydrochloride 5 mgAlso: Diupress® (Eurofarma Laboratórios Ltda.)Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks	Drug	Diupress®
Higroton® Laboratório NovartisChlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks	Drug	Higroton®

Primary outcome

Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
Time frame: Visit 4 (75 ± 3 days of V1)
V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)

1 secondary outcome

Blood Pressure
Time frame: Visit 4 (75 ± 3 days of V1)

Results and safety

Results posted to the registry on 12 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Higroton®	121	106
Diupress®	122	104

Primary outcome: Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4

Time frame: Visit 4 (75 ± 3 days of V1). Count of participants. Unit: Participants

Measure	Diupress® n = 122	Higroton® n = 121
V1 (15 ± 3 days after V0)	18	19
V2 (30 ± 3 days after V0)	25	51
V3 (60 ± 3 days after V0)	31	52
V4 (90 ± 3 days after V0)	36	51

Population analysed: Analysis of ITT. The number of participants differed across visits due to variations in attendance.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Higroton®	1 of 121 (0.8%)	41 of 121 (33.9%)	Not reported
Diupress®	2 of 122 (1.6%)	55 of 122 (45.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Paulo Guilherme O Silva principal investigator

Hospital Santa Marcelina

Humberto Freitas principal investigator

Hospital São Camilo

Jose Carlos A Ayob principal investigator

Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 14 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

Yes. Results are posted in the registry (first posted 12 Jun 2025). 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?

Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 (time frame: Visit 4 (75 ± 3 days of V1)). 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 NCT01191450.

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 12 Jun 2025.