Clinical trial NCT01191450: Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arterial Hypertension
Keywords: chlortalidone
amiloride
arterial hypertension
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 246
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
timeFrame: Visit 4 (75 ± 3 days of V1)
Secondary outcomes:
measure: Blood Pressure
timeFrame: Visit 4 (75 ± 3 days of V1)
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Centro de Estudos de Diabetes e Hipertensão
state: Ceará
city: Vitória
country: Brazil
facility: CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
state: Espirito Santo
city: Goiânia
country: Brazil
facility: Liga de Hipertensão Arterial - Universidade Federal de Goiás
state: Goiás
city: Botucatu
country: Brazil
facility: UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares
state: São Paulo
city: Tatuí
country: Brazil
facility: Instituto de Moléstias Cardiovasculares de Tatuí
state: São Paulo
city: São Paulo
country: Brazil
facility: Clínica Paulista de Doenças Cardiovasculares - FGM
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: São Paulo
country: Brazil
facility: Hospital São Camilo
city: São Paulo
country: Brazil
facility: IMA - Instituto de Medicina Avançada
Study officials:
affiliation: Hospital Santa Marcelina
name: Paulo Guilherme O Silva
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Camilo
name: Humberto Freitas
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares
name: Jose Carlos A Ayob
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP
name: Roberto Jorge S Franco
role: PRINCIPAL_INVESTIGATOR
affiliation: FGM - Clínica Paulista de Doenças Cardiovasculares
name: Fernando Augusto A Costa
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Estudos de Diabetes e Hipertensão
name: Adriana C Forti
role: PRINCIPAL_INVESTIGATOR
affiliation: Liga de Hipertensão Arterial - Universidade Federal de Goiás
name: Paulo Cesar V Jardim
role: PRINCIPAL_INVESTIGATOR
affiliation: IMA - Instituto de Medicina Avançada
name: Marise L Castro
role: PRINCIPAL_INVESTIGATOR
affiliation: CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo
name: Daniela G Barbieri
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Moléstias Cardiovasculares de Tatuí
name: Fábio José C Fucci
role: PRINCIPAL_INVESTIGATOR
References: