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

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Arterial Hypertension

Treatments: Drug: Higroton® Laboratório Novartis; Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191450

EF 114

Details and patient eligibility

About

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.

Full 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

Enrollment: 246 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Higroton®

Active Comparator group

Description:

Chlorthalidone 25mg - one oral tablet a day in the morning

Treatment:

Drug: Higroton® Laboratório Novartis

Diupress®

Experimental group

Description:

Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning

Treatment:

Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg