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

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.

Study Overview

• Status: Completed
• Conditions: Arterial Hypertension
• Intervention / Treatment: Drug: Higroton® Laboratório Novartis; Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg

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

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Higroton®; Chlorthalidone 25mg - one oral tablet a day in the morning	Drug: Higroton® Laboratório Novartis; Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
Experimental: Diupress®; Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning	Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg; Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks; Other Names: Diupress® (Eurofarma Laboratórios Ltda.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Visit 4 (75 ± 3 days of V1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Visit 4 (75 ± 3 days of V1)

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.
• Investigators: Principal Investigator: Paulo Guilherme O Silva, Hospital Santa Marcelina; Principal Investigator: Humberto Freitas, Hospital São Camilo; Principal Investigator: Jose Carlos A Ayob, Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares; Principal Investigator: Roberto Jorge S Franco, Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP; Principal Investigator: Fernando Augusto A Costa, FGM - Clínica Paulista de Doenças Cardiovasculares; Principal Investigator: Adriana C Forti, Centro de Estudos de Diabetes e Hipertensão; Principal Investigator: Paulo Cesar V Jardim, Liga de Hipertensão Arterial - Universidade Federal de Goiás; Principal Investigator: Marise L Castro, IMA - Instituto de Medicina Avançada; Principal Investigator: Daniela G Barbieri, CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo; Principal Investigator: Fábio José C Fucci, Instituto de Molestias Cardiovasculares de Tatui

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimated): August 30, 2010

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: arterial hypertension; amiloride; chlortalidone
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium Channel Blockers; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Antihypertensive Agents; Diuretics, Potassium Sparing; Sodium Chloride Symporter Inhibitors; Acid Sensing Ion Channel Blockers; Epithelial Sodium Channel Blockers; Chlorthalidone; Amiloride
• Other Study ID Numbers: EF 114