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

January 31, 2012 updated by: Eurofarma Laboratorios S.A.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Hospital Santa Marcelina
        • Contact:
        • Principal Investigator:
          • Paulo Guilherme O Silva
      • São Paulo, Brazil
        • Recruiting
        • Clínica Paulista de Doenças Cardiovasculares - FGM
        • Contact:
          • Raquel
          • Phone Number: 55 11 3373-7310
        • Principal Investigator:
          • Fernando Augusto A Costa
      • São Paulo, Brazil
        • Recruiting
        • Hospital São Camilo
        • Contact:
        • Principal Investigator:
          • Humberto Freitas
      • São Paulo, Brazil
        • Recruiting
        • IMA - Instituto de Medicina Avançada
        • Contact:
        • Principal Investigator:
          • Marise L Castro
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Recruiting
        • Centro de Estudos de Diabetes e Hipertensão
        • Contact:
        • Principal Investigator:
          • Adriana C Forti
    • Espirito Santo
      • Vitória, Espirito Santo, Brazil
        • Recruiting
        • CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
        • Contact:
        • Principal Investigator:
          • Daniela G Barbieri
    • Goiás
      • Goiânia, Goiás, Brazil
        • Recruiting
        • Liga de Hipertensão Arterial - Universidade Federal de Goiás
        • Contact:
        • Principal Investigator:
          • Paulo Cesar V Jardim
    • São Paulo
      • Botucatu, São Paulo, Brazil
        • Recruiting
        • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP
        • Contact:
        • Sub-Investigator:
          • Roberto Jorge S Franco
      • São José do Rio Preto, São Paulo, Brazil
        • Recruiting
        • Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares
        • Contact:
        • Principal Investigator:
          • José Carlos A Ayoub
      • Tatuí, São Paulo, Brazil
        • Recruiting
        • Instituto de Molestias Cardiovasculares de Tatui
        • Contact:
        • Principal Investigator:
          • Fábio José C Fucci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Higroton®
Chlorthalidone 25mg - one oral tablet a day in the morning
Drug: Higroton® Laboratório Novartis
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
Experimental: Diupress®
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potassium level
Time Frame: After starting the medication
Potassium level <4.0 mEq/L after starting the medication.
After starting the medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: After 12 weeks of treatment
Will be considered as secondary outcomes BP <140 X 90 mmHg after 12 weeks of treatment.
After 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Investigators

  • Principal Investigator: Paulo Guilherme O Silva, Hospital Santa Marcelina
  • Principal Investigator: Humberto Freitas, Hospital São Camilo
  • Principal Investigator: Jose Carlos A Ayob, Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares
  • Principal Investigator: Roberto Jorge S Franco, Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP
  • Principal Investigator: Fernando Augusto A Costa, FGM - Clínica Paulista de Doenças Cardiovasculares
  • Principal Investigator: Adriana C Forti, Centro de Estudos de Diabetes e Hipertensão
  • Principal Investigator: Paulo Cesar V Jardim, Liga de Hipertensão Arterial - Universidade Federal de Goiás
  • Principal Investigator: Marise L Castro, IMA - Instituto de Medicina Avançada
  • Principal Investigator: Daniela G Barbieri, CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
  • Principal Investigator: Fábio José C Fucci, Instituto de Molestias Cardiovasculares de Tatui

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF 114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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