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Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension (OPTION TREAT)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
candesartan cilexetil + chlorthalidone + amlodipine
Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both genders aged 18 years or older; Currently on dual antihypertensive therapy for at least 8 weeks, and non responders to that treatment, defined as measurements of SBP ≥ 140 mmHg and ≤180 mmHg and/or DBP≥90mmHg and ≤110 mmHg, assessed at the screening visit and randomization visit (both conditions are in accordance with the Brazilian Hypertension Guideline - 2020); Able to understand and consent to their participation in this clinical trial, manifested by signing the Informed Consent Form; Exclusion Criteria: Any significant clinical condition that, in the investigator's opinion, may interfere with participant safety; Any laboratory test finding that, in the investigator's opinion, may interfere with participant safety; Suspected or diagnosed with COVID 19; History of hypersensitivity to components of drugs used during the trial or to drugs derived from sulfonamides; Pregnant or breastfeeding women; Women in a reproductive age who do not agree to use contraceptive methods; Male participants who do not agree to use contraceptive methods; Participation in clinical trial protocols in the last 12 (twelve) months, unless the investigator judges that there may be a direct benefit to the participant; Participant who has some kind of relationship up to the second degree or bond with collaborators or employees of the Sponsor and the Research site; Estimated glomerular filtration rate (eGFR) less than 45 ml/min /1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) or end-stage renal disease; Severe liver dysfunction; Cardiogenic shock or reduced ejection fraction heart failure with a left ventricular ejection fraction less than or equal to 50%; Symptomatic congestive heart failure class II, III or IV, according to the New York Heart Association and/or participants with a history of infarction, unstable angina or cerebrovascular accident in the last 6 months prior to the beginning of the study; Clinically relevant ventricular cardiac arrhythmias; Obstructive coronary artery disease; Dementia syndrome; History of alcohol or illicit drug addiction in the six months prior to the date of signature of the Informed Consent Form; Obstructive biliary disorders; Refractory hypokalemia and/or conditions involving marked potassium loss, hyperkalemia, and/or hyponatremia; History of symptomatic hyperuricemia; History of secondary hypertension; History of cancer, without documentation of remission/cure;

Sites / Locations

  • Hospital de Urgência e Emergência de Rio Branco
  • Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas)
  • Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA
  • Vitoria Clinical Research Institute LTDA
  • Santa Casa de Misericórdia de Passos
  • Hospital Universitário Joao de Barros Barreto - UFPA
  • Hospital 9 de Julho
  • Instituto Atena de Pesquisa Clinica LTDA
  • Hospital de Clínicas de Porto Alegre
  • CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
  • Centro de Pesquisa Clínica do Coração
  • Hospital Universitário São Francisco de AssisRecruiting
  • Instituto de Pesquisa Clínica de Campinas
  • Hospital M'Boi Mirim
  • LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA.
  • Indacor Serviços Médicos
  • CIPES Centro Internacional de Pesquisa Clínica LTDA
  • Clínica Cardiológica
  • Santa Casa de Misericordia de Votuporanga
  • Hospital Universitário Pedro Ernesto/UERJ
  • InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
  • Associação Lar São Francisco de Assis na Providência de Deus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Association of candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg

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

Arm Description

The participant will take, once a day, 01 tablet of the active experimental drug (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg), plus 01 placebo, both orally.

The participant will take 01 tablet of Exforge HCT® active comparator (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) plus 01 placebo, both orally.

Outcomes

Primary Outcome Measures

Mean change in systolic blood pressure (SBP)
The primary efficacy endpoint is the mean change in systolic blood pressure, measured at the site, 12 weeks after starting treatment, compared to baseline.

Secondary Outcome Measures

Mean change in diastolic blood pressure (DBP)
Variation in diastolic blood pressure 4, 6 and 12 weeks after starting treatment
Participants with blood pressure (SBP <140 and DBP<90 mmHg)
Proportion of participants who reach the target blood pressure (SBP <140 and DBP<90mmHg) 4, 8 and 12 weeks after starting treatment
Participants with SBP <120 mmHg
Proportion of participants who reach the target blood pressure of SBP <120 mmHg 4, 8 and 12 weeks after starting treatment
Participants with SBP <140 mmHg
Proportion of participants who reach target systolic blood pressure (SBP <140 mmHg) 4, 8 and 12 weeks after starting treatment
Participants with DBP<90 mmHg
Proportion of participants who reach the target diastolic blood pressure (DBP<90 mmHg) 4, 8 and 12 weeks after starting treatment
Participants with reduction greater than or equal to 20 mmHg in SBP
Proportion of participants who show a reduction greater than or equal to 20 mmHg in systolic blood pressure 4, 8 and 12 weeks after the start of treatment
Participants with reduction greater than or equal to 10 mmHg in DBP
Proportion of participants who have a reduction greater than or equal to 10 mmHg in diastolic blood pressure 4, 8 and 12 weeks after starting treatment

Full Information

First Posted
June 16, 2023
Last Updated
August 23, 2023
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Libbs Farmacêutica LTDA
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1. Study Identification

Unique Protocol Identification Number
NCT05920005
Brief Title
Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension
Acronym
OPTION TREAT
Official Title
A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Libbs Farmacêutica LTDA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This phase III, multicenter, randomized, double-blind, controlled, parallel trial will evaluate the non-inferiority of the association between candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg in relation to Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12 5mg + amlodipine 5mg) in the treatment of systemic arterial hypertension. A total of 698 participants will be included. Follow-up visits will occur four, eight, and twelve weeks after the date of the randomization visit. A telephone contact will be performed 30 days after the end of treatment. The primary efficacy outcome is the mean change in blood pressure, measured at the research site, 12 weeks after starting treatment, compared to baseline. Incidence of adverse events will be collected from the first dose of treatment up to 30 days after the end of the treatment foreseen in the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, double-blind, phase III, parallel, controlled and randomized clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The experimental/comparator drug has different characteristics. To allow blinding, the Double-Dummy method will be performed, where study sites will receive two drug presentations (active and placebo), thus preventing any violation of blinding.
Allocation
Randomized
Enrollment
698 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Association of candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg
Arm Type
Experimental
Arm Description
The participant will take, once a day, 01 tablet of the active experimental drug (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg), plus 01 placebo, both orally.
Arm Title
Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Arm Type
Active Comparator
Arm Description
The participant will take 01 tablet of Exforge HCT® active comparator (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) plus 01 placebo, both orally.
Intervention Type
Drug
Intervention Name(s)
candesartan cilexetil + chlorthalidone + amlodipine
Intervention Description
Antihypertensive drugs in a single tablet (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg)
Intervention Type
Drug
Intervention Name(s)
Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Intervention Description
Antihypertensive drugs in a single tablet (association valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Primary Outcome Measure Information:
Title
Mean change in systolic blood pressure (SBP)
Description
The primary efficacy endpoint is the mean change in systolic blood pressure, measured at the site, 12 weeks after starting treatment, compared to baseline.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean change in diastolic blood pressure (DBP)
Description
Variation in diastolic blood pressure 4, 6 and 12 weeks after starting treatment
Time Frame
12 weeks
Title
Participants with blood pressure (SBP <140 and DBP<90 mmHg)
Description
Proportion of participants who reach the target blood pressure (SBP <140 and DBP<90mmHg) 4, 8 and 12 weeks after starting treatment
Time Frame
12 weeks
Title
Participants with SBP <120 mmHg
Description
Proportion of participants who reach the target blood pressure of SBP <120 mmHg 4, 8 and 12 weeks after starting treatment
Time Frame
12 weeks
Title
Participants with SBP <140 mmHg
Description
Proportion of participants who reach target systolic blood pressure (SBP <140 mmHg) 4, 8 and 12 weeks after starting treatment
Time Frame
12 weeks
Title
Participants with DBP<90 mmHg
Description
Proportion of participants who reach the target diastolic blood pressure (DBP<90 mmHg) 4, 8 and 12 weeks after starting treatment
Time Frame
12 weeks
Title
Participants with reduction greater than or equal to 20 mmHg in SBP
Description
Proportion of participants who show a reduction greater than or equal to 20 mmHg in systolic blood pressure 4, 8 and 12 weeks after the start of treatment
Time Frame
12 weeks
Title
Participants with reduction greater than or equal to 10 mmHg in DBP
Description
Proportion of participants who have a reduction greater than or equal to 10 mmHg in diastolic blood pressure 4, 8 and 12 weeks after starting treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders aged 18 years or older; Currently on dual antihypertensive therapy for at least 8 weeks, and non responders to that treatment, defined as measurements of SBP ≥ 140 mmHg and ≤180 mmHg and/or DBP≥90mmHg and ≤110 mmHg, assessed at the screening visit and randomization visit (both conditions are in accordance with the Brazilian Hypertension Guideline - 2020); Able to understand and consent to their participation in this clinical trial, manifested by signing the Informed Consent Form; Exclusion Criteria: Any significant clinical condition that, in the investigator's opinion, may interfere with participant safety; Any laboratory test finding that, in the investigator's opinion, may interfere with participant safety; Suspected or diagnosed with COVID 19; History of hypersensitivity to components of drugs used during the trial or to drugs derived from sulfonamides; Pregnant or breastfeeding women; Women in a reproductive age who do not agree to use contraceptive methods; Male participants who do not agree to use contraceptive methods; Participation in clinical trial protocols in the last 12 (twelve) months, unless the investigator judges that there may be a direct benefit to the participant; Participant who has some kind of relationship up to the second degree or bond with collaborators or employees of the Sponsor and the Research site; Estimated glomerular filtration rate (eGFR) less than 45 ml/min /1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) or end-stage renal disease; Severe liver dysfunction; Cardiogenic shock or reduced ejection fraction heart failure with a left ventricular ejection fraction less than or equal to 50%; Symptomatic congestive heart failure class II, III or IV, according to the New York Heart Association and/or participants with a history of infarction, unstable angina or cerebrovascular accident in the last 6 months prior to the beginning of the study; Clinically relevant ventricular cardiac arrhythmias; Obstructive coronary artery disease; Dementia syndrome; History of alcohol or illicit drug addiction in the six months prior to the date of signature of the Informed Consent Form; Obstructive biliary disorders; Refractory hypokalemia and/or conditions involving marked potassium loss, hyperkalemia, and/or hyponatremia; History of symptomatic hyperuricemia; History of secondary hypertension; History of cancer, without documentation of remission/cure;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vagner Madrini Junior, MD
Phone
+55 11 2151-5915
Email
vagner.junior@einstein.br
First Name & Middle Initial & Last Name or Official Title & Degree
Diogo Moia, MD
Phone
+55 11 2151-5915
Email
diogo.moia@einstein.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrícia Oliveira Guimarães, MD, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Urgência e Emergência de Rio Branco
City
Rio Branco
State/Province
AC
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odilson Silvestre, MD-PhD
First Name & Middle Initial & Last Name & Degree
Odilson Silvestre
Facility Name
Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas)
City
Maceió
State/Province
Alagoas
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Antonio Mota Gomes, MD
Facility Name
Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA
City
Fortaleza
State/Province
Ceará
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Nasser Hissa
Facility Name
Vitoria Clinical Research Institute LTDA
City
Vitória
State/Province
Espírito Santo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla Aquino Martins, MD
Facility Name
Santa Casa de Misericórdia de Passos
City
Passos
State/Province
MG
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Alvarenga, MD
Facility Name
Hospital Universitário Joao de Barros Barreto - UFPA
City
Belém
State/Province
Pará
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João Soares Felício, MD
Facility Name
Hospital 9 de Julho
City
Sao Paulo
State/Province
Please Select
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Lima, MD, PhD
Facility Name
Instituto Atena de Pesquisa Clinica LTDA
City
Natal
State/Province
Rio Grande Do Norte
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Sanali Moura de Oliveira Paiva, MD
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-007
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávio Danni Fuchs, MD, PhD
Phone
(51) 3359-8000
Email
ffuchs@hcpa.edu.br
Facility Name
CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
City
Joinville
State/Province
Santa Catarina
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conrado Hoffmann Filho, MD, PhD
Email
conrado@corsanus.com.br
Facility Name
Centro de Pesquisa Clínica do Coração
City
Aracaju
State/Province
SE
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Silveira
First Name & Middle Initial & Last Name & Degree
Fabio Silveira, MD
Facility Name
Hospital Universitário São Francisco de Assis
City
Bragança Paulista
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murillo Antunes
First Name & Middle Initial & Last Name & Degree
Murillo Antunes, MD
Facility Name
Instituto de Pesquisa Clínica de Campinas
City
Campinas
State/Province
SP
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Francisco Saraiva
First Name & Middle Initial & Last Name & Degree
Jose Francisco Saraiva, MD
Facility Name
Hospital M'Boi Mirim
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Campos, MD
Facility Name
LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA.
City
Campinas
State/Province
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Helena Vidotti
First Name & Middle Initial & Last Name & Degree
Maria Helena Vidotti, MD
Facility Name
Indacor Serviços Médicos
City
Indaiatuba
State/Province
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávio Souza Brito, MD
Facility Name
CIPES Centro Internacional de Pesquisa Clínica LTDA
City
São José Dos Campos
State/Province
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabiana Goulart Marcondes Braga, MD, PhD
Facility Name
Clínica Cardiológica
City
Votuporanga
State/Province
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Espirito Santo Cestario, MD
Facility Name
Santa Casa de Misericordia de Votuporanga
City
Votuporanga
State/Province
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro E Hernandes, MD
First Name & Middle Initial & Last Name & Degree
Mauro E Hernandes, MD
Facility Name
Hospital Universitário Pedro Ernesto/UERJ
City
Rio De Janeiro
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Araujo Brandão, MD
Facility Name
InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiz A Bortolotto, MD, PhD
Phone
(11) 2661-5000
Email
luiz.bortolotto@incor.usp.br
Facility Name
Associação Lar São Francisco de Assis na Providência de Deus
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Troiani do Nascimento

12. IPD Sharing Statement

Learn more about this trial

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

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