Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
- Conditions
- Arterial Hypertension
- Interventions
- Drug: Higroton® Laboratório Novartis
- Registration Number
- NCT01191450
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 280
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Higroton® Higroton® Laboratório Novartis Chlorthalidone 25mg - one oral tablet a day in the morning Diupress® Chlorthalidone 25 mg + amiloride hydrochloride 5 mg Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
- Primary Outcome Measures
Name Time Method Potassium level After starting the medication Potassium level \<4.0 mEq/L after starting the medication.
- Secondary Outcome Measures
Name Time Method Blood Pressure After 12 weeks of treatment Will be considered as secondary outcomes BP \<140 X 90 mmHg after 12 weeks of treatment.
Trial Locations
- Locations (10)
Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares
🇧🇷São José do Rio Preto, São Paulo, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP
🇧🇷Botucatu, São Paulo, Brazil
IMA - Instituto de Medicina Avançada
🇧🇷São Paulo, Brazil
Centro de Estudos de Diabetes e Hipertensão
🇧🇷Fortaleza, Ceará, Brazil
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
🇧🇷Vitória, Espirito Santo, Brazil
Liga de Hipertensão Arterial - Universidade Federal de Goiás
🇧🇷Goiânia, Goiás, Brazil
Clínica Paulista de Doenças Cardiovasculares - FGM
🇧🇷São Paulo, Brazil
Hospital São Camilo
🇧🇷São Paulo, Brazil
Instituto de Moléstias Cardiovasculares de Tatuí
🇧🇷Tatuí, São Paulo, Brazil
Hospital Santa Marcelina
🇧🇷São Paulo, Brazil