Study Stopped
Decided by Sponsor
Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedDecember 8, 2025
December 1, 2025
July 6, 2015
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
60 days
Secondary Outcomes (1)
Safety will be evaluated by the occurrences of adverse events.
9 weeks
Study Arms (3)
Test 1: Olmesartan + Chlorthalidone
EXPERIMENTALThe patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Test 2: Olmesartan + Chlorthalidone
EXPERIMENTALThe patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 25 mg) a day, in the morning.
Comparator: Benicar HCT®
EXPERIMENTALThe patients will take 1 tablet (Olmesartan 20 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
Interventions
1 tablet a day
1 tablet a day
Eligibility Criteria
You may qualify if:
- 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 have never been treated and have indication for drug combination treatment.
- Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements
You may not qualify if:
- Patients with any clinically significant disease that in the investigator is 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 in urine sample greater than 30 mg/g;
- Patients with history of hypersensitivity to any of the formula compounds;
- Pregnancy or risk of pregnancy and lactating patients;
- Participation in clinical trial in the year prior to this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2015
First Posted
July 9, 2015
Primary Completion
June 1, 2025
Last Updated
December 8, 2025
Record last verified: 2025-12