Clinical trial
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
Name
OLCEMS0514OR-III
Description
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.
Trial arms
Trial start
2024-12-01
Estimated PCD
2026-06-01
Trial end
2026-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg
1 tablet a day
Arms:
Test 1: Olmesartan + Chlorthalidone
Olmesartan medoxomil 20mg + Chlortalidone 25mg
1 tablet a day
Arms:
Test 2: Olmesartan + Chlorthalidone
Olmesartan 20mg + hydrochlorothiazide 12,5mg
1 tablet a day
Arms:
Comparator: Benicar HCT®
Other names:
Benicar HCT®
Size
261
Primary endpoint
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
60 days
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 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:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 261, 'type': 'ESTIMATED'}}
Updated at
2024-02-16
1 organization
4 products
1 indication
Organization
EMSIndication
Essential hypertension