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

Primary Purpose

Arterial Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg
Higroton® Laboratório Novartis
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension focused on measuring chlortalidone, amiloride, arterial hypertension

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centro de Estudos de Diabetes e HipertensãoRecruiting
  • CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito SantoRecruiting
  • Liga de Hipertensão Arterial - Universidade Federal de GoiásRecruiting
  • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESPRecruiting
  • Centro de Pesquisa Clínica do IMC - Instituto de Moléstias CardiovascularesRecruiting
  • Instituto de Moléstias Cardiovasculares de TatuíRecruiting
  • Clínica Paulista de Doenças Cardiovasculares - FGMRecruiting
  • Hospital Santa MarcelinaRecruiting
  • Hospital São CamiloRecruiting
  • IMA - Instituto de Medicina AvançadaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Higroton®

Diupress®

Arm Description

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

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

Outcomes

Primary Outcome Measures

Potassium level
Potassium level <4.0 mEq/L after starting the medication.

Secondary Outcome Measures

Blood Pressure
Will be considered as secondary outcomes BP <140 X 90 mmHg after 12 weeks of treatment.

Full Information

First Posted
August 26, 2010
Last Updated
January 31, 2012
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01191450
Brief Title
Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
Acronym
CARD
Official Title
A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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, 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
chlortalidone, amiloride, arterial hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Higroton®
Arm Type
Active Comparator
Arm Description
Chlorthalidone 25mg - one oral tablet a day in the morning
Arm Title
Diupress®
Arm Type
Experimental
Arm Description
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Intervention Type
Drug
Intervention Name(s)
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg
Other Intervention Name(s)
Diupress® (Eurofarma Laboratórios Ltda.)
Intervention Description
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
Intervention Type
Drug
Intervention Name(s)
Higroton® Laboratório Novartis
Intervention Description
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
Primary Outcome Measure Information:
Title
Potassium level
Description
Potassium level <4.0 mEq/L after starting the medication.
Time Frame
After starting the medication
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Will be considered as secondary outcomes BP <140 X 90 mmHg after 12 weeks of treatment.
Time Frame
After 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estela B Pannuti
Phone
55 11 4144-9680
Email
estela.pannuti@eurofarma.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Guilherme O Silva
Organizational Affiliation
Hospital Santa Marcelina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Humberto Freitas
Organizational Affiliation
Hospital São Camilo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Carlos A Ayob
Organizational Affiliation
Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Jorge S Franco
Organizational Affiliation
Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Augusto A Costa
Organizational Affiliation
FGM - Clínica Paulista de Doenças Cardiovasculares
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adriana C Forti
Organizational Affiliation
Centro de Estudos de Diabetes e Hipertensão
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo Cesar V Jardim
Organizational Affiliation
Liga de Hipertensão Arterial - Universidade Federal de Goiás
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marise L Castro
Organizational Affiliation
IMA - Instituto de Medicina Avançada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniela G Barbieri
Organizational Affiliation
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fábio José C Fucci
Organizational Affiliation
Instituto de Moléstias Cardiovasculares de Tatuí
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Estudos de Diabetes e Hipertensão
City
Fortaleza
State/Province
Ceará
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviana
Phone
55 85 3105-8300
Email
cedh@cedh.med.br
First Name & Middle Initial & Last Name & Degree
Adriana C Forti
Facility Name
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
City
Vitória
State/Province
Espirito Santo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Carolina
Phone
55 27 21250220
Email
pesquisa2@cedoes.com.br
First Name & Middle Initial & Last Name & Degree
Daniela G Barbieri
Facility Name
Liga de Hipertensão Arterial - Universidade Federal de Goiás
City
Goiânia
State/Province
Goiás
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Paula Souza
Phone
55 62 3269-8433
Email
anapauladesouza@hotmail.com
First Name & Middle Initial & Last Name & Degree
Paulo Cesar V Jardim
Facility Name
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP
City
Botucatu
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mônica
Phone
55 14 3811-6574
Email
mapaula@fmb.unesp.br
First Name & Middle Initial & Last Name & Degree
Roberto Jorge S Franco
Facility Name
Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares
City
São José do Rio Preto
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clotilde
Phone
55 17 3203-4051
Email
dcimc@imconline.com.br
First Name & Middle Initial & Last Name & Degree
José Carlos A Ayoub
Facility Name
Instituto de Moléstias Cardiovasculares de Tatuí
City
Tatuí
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Frare
Phone
55 15 3305 1260
Email
lucasfrare@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Fábio José C Fucci
Facility Name
Clínica Paulista de Doenças Cardiovasculares - FGM
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel
Phone
55 11 3373-7310
First Name & Middle Initial & Last Name & Degree
Fernando Augusto A Costa
Facility Name
Hospital Santa Marcelina
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel
Phone
55 11 2217-3766
Email
isabelcpchsm@santamarcelina.org
First Name & Middle Initial & Last Name & Degree
Paulo Guilherme O Silva
Facility Name
Hospital São Camilo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Gonçalves
Phone
55 11 3677-4444
Ext
5015
Email
pesquisa.iep@saocamilo.com
First Name & Middle Initial & Last Name & Degree
Humberto Freitas
Facility Name
IMA - Instituto de Medicina Avançada
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Fakih
Phone
55 11 38639156
Email
daniela.fakih@imabrasil.com.br
First Name & Middle Initial & Last Name & Degree
Marise L Castro

12. IPD Sharing Statement

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

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