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 August 23, 2015 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 ClÃnicas do Instituto de Moléstias Cardiovasculares Roberto Jorge S Franco, Principal Investigator, Affiliation: Unidade de Pesquisa ClÃnica (UPECLIN)- Hospital das ClÃnicas UNESP Fernando Augusto A Costa, Principal Investigator, Affiliation: FGM - ClÃnica 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 EspÃrito Santo Fábio José C Fucci, Principal Investigator, Affiliation: Instituto de Moléstias Cardiovasculares de TatuÃ
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® 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
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
ClÃnica 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 EspÃrito 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 ClÃnica 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 ClÃnica 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 TatuÃ, TatuÃ, 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
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