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

NCT01191450 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-06-12

Study results available
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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.

Conditions

  • Arterial Hypertension

Interventions

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

DRUG

Higroton® Laboratório Novartis

Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • Paulo Guilherme O Silva · Hospital Santa Marcelina

  • Humberto Freitas · Hospital São Camilo

  • Jose Carlos A Ayob · Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares

  • Roberto Jorge S Franco · Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP

  • Fernando Augusto A Costa · FGM - Clínica Paulista de Doenças Cardiovasculares

  • Adriana C Forti · Centro de Estudos de Diabetes e Hipertensão

  • Paulo Cesar V Jardim · Liga de Hipertensão Arterial - Universidade Federal de Goiás

  • Marise L Castro · IMA - Instituto de Medicina Avançada

  • Daniela G Barbieri · CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo

  • Fábio José C Fucci · Instituto de Moléstias Cardiovasculares de Tatuí

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191450 on ClinicalTrials.gov