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

Arterial Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01191450
• Other study ID #: EF 114
• Status: Recruiting
• Phase: Phase 3
• First received: August 26, 2010
• Last updated: January 31, 2012
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2012
• Source: Eurofarma Laboratorios S.A.
• Contact: Estela B Pannuti
• Phone: 55 11 4144-9680
• Email: estela.pannuti[@]eurofarma.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

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
• Higroton® Laboratório Novartis
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks

Locations

Country	Name	City	State
Brazil	UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP	Botucatu	São Paulo
Brazil	Centro de Estudos de Diabetes e Hipertensão	Fortaleza	Ceará
Brazil	Liga de Hipertensão Arterial - Universidade Federal de Goiás	Goiânia	Goiás
Brazil	Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares	São José do Rio Preto	São Paulo
Brazil	Clínica Paulista de Doenças Cardiovasculares - FGM	São Paulo
Brazil	Hospital Santa Marcelina	São Paulo
Brazil	Hospital São Camilo	São Paulo
Brazil	IMA - Instituto de Medicina Avançada	São Paulo
Brazil	Instituto de Moléstias Cardiovasculares de Tatuí	Tatuí	São Paulo
Brazil	CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo	Vitória	Espirito Santo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potassium level	Potassium level <4.0 mEq/L after starting the medication.	After starting the medication	Yes
Secondary	Blood Pressure	Will be considered as secondary outcomes BP <140 X 90 mmHg after 12 weeks of treatment.	After 12 weeks of treatment	Yes