Status:
COMPLETED
Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Arterial Hypertension
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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, compa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT01191450
Start Date
August 1 2011
End Date
August 1 2013
Last Update
June 12 2025
Active Locations (10)
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1
Centro de Estudos de Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
2
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
Vitória, Espírito Santo, Brazil
3
Liga de Hipertensão Arterial - Universidade Federal de Goiás
Goiânia, Goiás, Brazil
4
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP
Botucatu, São Paulo, Brazil