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Efficacy of Chlorthalidone and Hydrochlorothiazide Combined With Amiloride on Blood Pressure in Primary Hypertension.

NCT03928145 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-12-09

No results posted yet for this study

Summary

Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, safety profile and low cost, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Besides, concernments about adverse metabolic effects such as hypokalemia, hyperglycemia and hyperlipidemia do exist, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. In addition to control adverse effects of thiazides, amiloride could offer an additional blood pressure lowering effect, but the efficacy of different doses was not fully established. This study aims to investigate the blood pressure lowering efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension.

Conditions

Interventions

DRUG

Chlorthalidone 25 mg

Chlorthalidone 25 mg taken orally in the morning for 12 weeks.

DRUG

Hydrochlorothiazide 50 mg

Hydrochlorothiazide 50 mg taken orally in the morning for 12 weeks.

DRUG

Amiloride 20 mg

Amiloride 20 mg taken orally in the morning for 12 weeks.

DRUG

Amiloride 10 mg

Amiloride 10 mg taken orally in the morning for 12 weeks.

Sponsors & Collaborators

  • Instituto de Cardiologia do Rio Grande do Sul

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Flavio Fuchs, MD, PhD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

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 NCT03928145 on ClinicalTrials.gov