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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Eurofarma Laboratorios S.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01191450
First received: August 26, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Arterial Hypertension
Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg
Drug: Higroton® Laboratório Novartis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Potassium level [ Time Frame: After starting the medication ] [ Designated as safety issue: Yes ]
    Potassium level <4.0 mEq/L after starting the medication.


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Will be considered as secondary outcomes BP <140 X 90 mmHg after 12 weeks of treatment.


Estimated Enrollment: 280
Study Start Date: August 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Higroton® Laboratório Novartis
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 Name: Diupress® (Eurofarma Laboratórios Ltda.)

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191450

Contacts
Contact: Estela B Pannuti 55 11 4144-9680 estela.pannuti@eurofarma.com.br

Locations
Brazil
Centro de Estudos de Diabetes e Hipertensão Recruiting
Fortaleza, Ceará, Brazil
Contact: Viviana    55 85 3105-8300    cedh@cedh.med.br   
Principal Investigator: Adriana C Forti         
CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo Recruiting
Vitória, Espirito Santo, Brazil
Contact: Ana Carolina    55 27 21250220    pesquisa2@cedoes.com.br   
Principal Investigator: Daniela G Barbieri         
Liga de Hipertensão Arterial - Universidade Federal de Goiás Recruiting
Goiânia, Goiás, Brazil
Contact: Ana Paula Souza    55 62 3269-8433    anapauladesouza@hotmail.com   
Principal Investigator: Paulo Cesar V Jardim         
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP Recruiting
Botucatu, São Paulo, Brazil
Contact: Mônica    55 14 3811-6574    mapaula@fmb.unesp.br   
Sub-Investigator: Roberto Jorge S Franco         
Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares Recruiting
São José do Rio Preto, São Paulo, Brazil
Contact: Clotilde    55 17 3203-4051    dcimc@imconline.com.br   
Principal Investigator: José Carlos A Ayoub         
Instituto de Moléstias Cardiovasculares de Tatuí Recruiting
Tatuí, São Paulo, Brazil
Contact: Lucas Frare    55 15 3305 1260    lucasfrare@yahoo.com.br   
Principal Investigator: Fábio José C Fucci         
Hospital Santa Marcelina Recruiting
São Paulo, Brazil
Contact: Isabel    55 11 2217-3766    isabelcpchsm@santamarcelina.org   
Principal Investigator: Paulo Guilherme O Silva         
Clínica Paulista de Doenças Cardiovasculares - FGM Recruiting
São Paulo, Brazil
Contact: Raquel    55 11 3373-7310      
Principal Investigator: Fernando Augusto A Costa         
IMA - Instituto de Medicina Avançada Recruiting
São Paulo, Brazil
Contact: Daniela Fakih    55 11 38639156    daniela.fakih@imabrasil.com.br   
Principal Investigator: Marise L Castro         
Hospital São Camilo Recruiting
São Paulo, Brazil
Contact: Mariana Gonçalves    55 11 3677-4444 ext 5015    pesquisa.iep@saocamilo.com   
Principal Investigator: Humberto Freitas         
Sponsors and Collaborators
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 Moléstias Cardiovasculares de Tatuí
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01191450     History of Changes
Other Study ID Numbers: EF 114
Study First Received: August 26, 2010
Last Updated: January 31, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios S.A.:
chlortalidone
amiloride
arterial hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Chlorthalidone
Lactitol
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014