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

• Status: Unknown status
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Amiloride; Chlorthalidone

Criteria

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