Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
NCT ID: NCT01191450
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
246 participants
INTERVENTIONAL
2011-08-31
2013-08-31
Brief Summary
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Detailed Description
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Some eligibility criteria:
perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Higroton®
Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
Diupress®
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
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
Interventions
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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
Higroton® Laboratório Novartis
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Eurofarma Laboratorios S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Paulo Guilherme O Silva
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa Marcelina
Humberto Freitas
Role: PRINCIPAL_INVESTIGATOR
Hospital São Camilo
Jose Carlos A Ayob
Role: PRINCIPAL_INVESTIGATOR
Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares
Roberto Jorge S Franco
Role: PRINCIPAL_INVESTIGATOR
Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP
Fernando Augusto A Costa
Role: PRINCIPAL_INVESTIGATOR
FGM - Clínica Paulista de Doenças Cardiovasculares
Adriana C Forti
Role: PRINCIPAL_INVESTIGATOR
Centro de Estudos de Diabetes e Hipertensão
Paulo Cesar V Jardim
Role: PRINCIPAL_INVESTIGATOR
Liga de Hipertensão Arterial - Universidade Federal de Goiás
Marise L Castro
Role: PRINCIPAL_INVESTIGATOR
IMA - Instituto de Medicina Avançada
Daniela G Barbieri
Role: PRINCIPAL_INVESTIGATOR
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
Fábio José C Fucci
Role: PRINCIPAL_INVESTIGATOR
Instituto de Moléstias Cardiovasculares de Tatuí
Locations
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Centro de Estudos de Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
Vitória, Espírito Santo, Brazil
Liga de Hipertensão Arterial - Universidade Federal de Goiás
Goiânia, Goiás, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP
Botucatu, São Paulo, Brazil
Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares
São José do Rio Preto, São Paulo, Brazil
Instituto de Moléstias Cardiovasculares de Tatuí
Tatuí, São Paulo, Brazil
Clínica Paulista de Doenças Cardiovasculares - FGM
São Paulo, , Brazil
Hospital Santa Marcelina
São Paulo, , Brazil
Hospital São Camilo
São Paulo, , Brazil
IMA - Instituto de Medicina Avançada
São Paulo, , Brazil
Countries
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Other Identifiers
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EF 114
Identifier Type: -
Identifier Source: org_study_id
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