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

Information source: Eurofarma Laboratorios S.A.
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arterial Hypertension

Intervention: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Drug); Higroton® Laboratório Novartis (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eurofarma Laboratorios S.A.

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

Overall contact:
Estela B Pannuti, Phone: 55 11 4144-9680, Email: estela.pannuti@eurofarma.com.br

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Potassium level

Secondary outcome: Blood Pressure

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 Laboratrio Novartis) in same presentation form. Some eligibility criteria: perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Estela B Pannuti, Phone: 55 11 4144-9680, Email: estela.pannuti@eurofarma.com.br

Clínica Paulista de Doenças Cardiovasculares - FGM, São Paulo, Brazil; Recruiting
Raquel, Phone: 55 11 3373-7310
Fernando Augusto A Costa, Principal Investigator

Hospital Santa Marcelina, São Paulo, Brazil; Recruiting
Isabel, Phone: 55 11 2217-3766, Email: isabelcpchsm@santamarcelina.org
Paulo Guilherme O Silva, Principal Investigator

Hospital São Camilo, São Paulo, Brazil; Recruiting
Mariana Gonçalves, Phone: 55 11 3677-4444, Ext: 5015, Email: pesquisa.iep@saocamilo.com
Humberto Freitas, Principal Investigator

IMA - Instituto de Medicina Avançada, São Paulo, Brazil; Recruiting
Daniela Fakih, Phone: 55 11 38639156, Email: daniela.fakih@imabrasil.com.br
Marise L Castro, Principal Investigator

Centro de Estudos de Diabetes e Hipertensão, Fortaleza, Ceará, Brazil; Recruiting
Viviana, Phone: 55 85 3105-8300, Email: cedh@cedh.med.br
Adriana C Forti, Principal Investigator

CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo, Vitória, Espirito Santo, Brazil; Recruiting
Ana Carolina, Phone: 55 27 21250220, Email: pesquisa2@cedoes.com.br
Daniela G Barbieri, Principal Investigator

Liga de Hipertensão Arterial - Universidade Federal de Goiás, Goiânia, Goiás, Brazil; Recruiting
Ana Paula Souza, Phone: 55 62 3269-8433, Email: anapauladesouza@hotmail.com
Paulo Cesar V Jardim, Principal Investigator

UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP, Botucatu, São Paulo, Brazil; Recruiting
Mônica, Phone: 55 14 3811-6574, Email: mapaula@fmb.unesp.br
Roberto Jorge S Franco, Sub-Investigator

Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares, São José do Rio Preto, São Paulo, Brazil; Recruiting
Clotilde, Phone: 55 17 3203-4051, Email: dcimc@imconline.com.br
José Carlos A Ayoub, Principal Investigator

Instituto de Moléstias Cardiovasculares de Tatuí, Tatuí, São Paulo, Brazil; Recruiting
Lucas Frare, Phone: 55 15 3305 1260, Email: lucasfrare@yahoo.com.br
Fábio José C Fucci, Principal Investigator

Additional Information

Starting date: August 2011
Last updated: January 31, 2012

Page last updated: November 27, 2014

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