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Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension

NCT05920005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2025-07-09

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of a new combination of 3 (three) antihypertensive drugs in a single pill (candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg) compared with another combination of 3 (three) antihypertensive drugs (Exforge HCT® \[valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg\]). This will be a non-inferiority trial and the primary outcome will be blood pressure control after 12 weeks of treatment.

Conditions

Interventions

DRUG

candesartan cilexetil + chlorthalidone + amlodipine

Antihypertensive drugs in a single tablet (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg)

DRUG

Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)

Antihypertensive drugs in a single tablet (association valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)

Sponsors & Collaborators

  • Libbs Farmacêutica LTDA

    collaborator INDUSTRY

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Patrícia Oliveira Guimarães, MD, PhD · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2025-03-31
Completion
2025-05-01

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT05920005 on ClinicalTrials.gov