Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
NCT ID: NCT02493322
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test 1: Olmesartan + Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg
1 tablet a day
Test 2: Olmesartan + Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 25 mg) a day, in the morning.
Olmesartan medoxomil 20mg + Chlortalidone 25mg
1 tablet a day
Comparator: Benicar HCT®
The patients will take 1 tablet (Olmesartan 20 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
Olmesartan 20mg + hydrochlorothiazide 12,5mg
1 tablet a day
Interventions
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Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg
1 tablet a day
Olmesartan medoxomil 20mg + Chlortalidone 25mg
1 tablet a day
Olmesartan 20mg + hydrochlorothiazide 12,5mg
1 tablet a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Other Identifiers
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OLCEMS0514OR-III
Identifier Type: -
Identifier Source: org_study_id
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