Skip to main content
OpenTrials
Completed

NCT Number: NCT01191450

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Estudos de Diabetes e Hipertensão, Fortaleza, Ceará, Brazil

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorthalidone 25 mg + amiloride hydrochloride 5 mg

Drug

Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks

Other names: Diupress® (Eurofarma Laboratórios Ltda.)

Higroton® Laboratório Novartis

Drug

Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks

Primary outcomes

  1. Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4

    Time frame: Visit 4 (75 ± 3 days of V1)

    V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)

Secondary outcomes

  1. Blood Pressure

    Time frame: Visit 4 (75 ± 3 days of V1)

    Will be considered as secondary outcomes BP <140 X 90 mmHg after Visit 4 (75 ± 3 days of V1).

    V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)

Sponsors and collaborators

Lead sponsor

Eurofarma Laboratorios S.A.

Industry

Registry information

Official study title

A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension

Acronym: CARD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2010
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.