Back to resultsEfficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control
Primary Purpose
Arterial Hypertension
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
Olmesartan medoxomil 40mg + chlorthalidone 25mg
Olmesartan 40mg + Hydrochlorothiazide 12,5mg
Olmesartan 40mg + Hydrochlorothiazide 25mg
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- Signed Consent of the patient;
- Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who are being treated with monotherapy.
Exclusion Criteria:
- Patients with any clinically significant disease that in the investigator opinion can not participate in the study;
- Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
- Morbid obesity or immunocompromised patients;
- Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
- Participants who do not have the two upper limbs;
- Participants with important electrocardiographic changes;
- Creatinine clearance - less than 60 mL / min;
- History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
- Microalbuminuria urine sample greater than 30 mg/g;
- Patients with history of hypersensitivity to any of the formula compounds;
- Pregnancy or risk of pregnancy and lactation patients;
- Participation in clinical trial in the year prior to this study;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Test 1: Olmesartan+Chlorthalidone
Test 2: Olmesartan+Chlorthalidone
Comparator 1: Benicar HCT®
Comparator 2: Benicar HCT®
Arm Description
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.
Outcomes
Primary Outcome Measures
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
Secondary Outcome Measures
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02483936
Brief Title
Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control
Official Title
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan Medoxomil + Chlorthalidone (40mg + 12.5mg and 40mg + 25mg) Compared With BENICAR HCT® in Hypertension Control
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
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
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
348 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test 1: Olmesartan+Chlorthalidone
Arm Type
Experimental
Arm Description
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Arm Title
Test 2: Olmesartan+Chlorthalidone
Arm Type
Experimental
Arm Description
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.
Arm Title
Comparator 1: Benicar HCT®
Arm Type
Active Comparator
Arm Description
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
Arm Title
Comparator 2: Benicar HCT®
Arm Type
Active Comparator
Arm Description
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
Intervention Description
1 tablet a day
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil 40mg + chlorthalidone 25mg
Intervention Description
1 tablet a day
Intervention Type
Drug
Intervention Name(s)
Olmesartan 40mg + Hydrochlorothiazide 12,5mg
Other Intervention Name(s)
Benicar HCT
Intervention Description
1 tablet a day
Intervention Type
Drug
Intervention Name(s)
Olmesartan 40mg + Hydrochlorothiazide 25mg
Other Intervention Name(s)
Benicar HCT
Intervention Description
1 tablet a day
Primary Outcome Measure Information:
Title
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Consent of the patient;
Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who are being treated with monotherapy.
Exclusion Criteria:
Patients with any clinically significant disease that in the investigator opinion can not participate in the study;
Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
Morbid obesity or immunocompromised patients;
Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
Participants who do not have the two upper limbs;
Participants with important electrocardiographic changes;
Creatinine clearance - less than 60 mL / min;
History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
Microalbuminuria urine sample greater than 30 mg/g;
Patients with history of hypersensitivity to any of the formula compounds;
Pregnancy or risk of pregnancy and lactation patients;
Participation in clinical trial in the year prior to this study;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monalisa F.B. Oliveira, M.D.
Phone
55
Email
pesquisa.clinica@ems.com.br
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control
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