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

NCT01191450 | Completed Phase 3 Results

• 1 other identifier: EF 114
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 10

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.

Conditions

Arterial Hypertension

Keywords

chlortalidone; amiloride; arterial hypertension

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4

  V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)

  Visit 4 (75 ± 3 days of V1)

Secondary Outcomes (1)

• Blood Pressure

  Visit 4 (75 ± 3 days of V1)

Study Arms (2)

Higroton®

ACTIVE COMPARATOR

Chlorthalidone 25mg - one oral tablet a day in the morning

Drug: Higroton® Laboratório Novartis

Diupress®

EXPERIMENTAL

Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning

Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg

Interventions

Chlorthalidone 25 mg + amiloride hydrochloride 5 mg DRUG

Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks

Also known as: Diupress® (Eurofarma Laboratórios Ltda.)

Diupress®

Higroton® Laboratório Novartis DRUG

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

Higroton®

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (10)

Centro de Estudos de Diabetes e Hipertensão

Fortaleza, Ceará, Brazil

Location

CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo

Vitória, Espírito Santo, Brazil

Location

Liga de Hipertensão Arterial - Universidade Federal de Goiás

Goiânia, Goiás, Brazil

Location

UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP

Botucatu, São Paulo, Brazil

Location

Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares

São José do Rio Preto, São Paulo, Brazil

Location

Instituto de Moléstias Cardiovasculares de Tatuí

Tatuí, São Paulo, Brazil

Location

Clínica Paulista de Doenças Cardiovasculares - FGM

São Paulo, Brazil

Location

Hospital Santa Marcelina

São Paulo, Brazil

Location

Hospital São Camilo

São Paulo, Brazil

Location

IMA - Instituto de Medicina Avançada

São Paulo, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Chlorthalidone; Amiloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Eurofarma Laboratórios S.A
• Organization: Eurofarma Laboratórios S.A

fernanda.martinez@eurofarma.com.br

50 11 5090-8415

Study Officials

• Paulo Guilherme O Silva

  Hospital Santa Marcelina

  PRINCIPAL INVESTIGATOR

• Humberto Freitas

  Hospital São Camilo

  PRINCIPAL INVESTIGATOR

• Jose Carlos A Ayob

  Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares

  PRINCIPAL INVESTIGATOR

• Roberto Jorge S Franco

  Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP

  PRINCIPAL INVESTIGATOR

• Fernando Augusto A Costa

  FGM - Clínica Paulista de Doenças Cardiovasculares

  PRINCIPAL INVESTIGATOR

• Adriana C Forti

  Centro de Estudos de Diabetes e Hipertensão

  PRINCIPAL INVESTIGATOR

• Paulo Cesar V Jardim

  Liga de Hipertensão Arterial - Universidade Federal de Goiás

  PRINCIPAL INVESTIGATOR

• Marise L Castro

  IMA - Instituto de Medicina Avançada

  PRINCIPAL INVESTIGATOR

• Daniela G Barbieri

  CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo

  PRINCIPAL INVESTIGATOR

• Fábio José C Fucci

  Instituto de Moléstias Cardiovasculares de Tatuí

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-03

Locations

BR (10)