Clinical trial
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
Name
OLCEMS0215
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
2025-06-01
Trial end
2026-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
1 tablet a day
Arms:
Test 1: Olmesartan+Chlorthalidone
Olmesartan medoxomil 40mg + chlorthalidone 25mg
1 tablet a day
Arms:
Test 2: Olmesartan+Chlorthalidone
Olmesartan 40mg + Hydrochlorothiazide 12,5mg
1 tablet a day
Arms:
Comparator 1: Benicar HCT®
Other names:
Benicar HCT
Olmesartan 40mg + Hydrochlorothiazide 25mg
1 tablet a day
Arms:
Comparator 2: Benicar HCT®
Other names:
Benicar HCT
Size
348
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 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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 348, 'type': 'ESTIMATED'}}
Updated at
2024-02-16
1 organization
5 products
1 indication
Organization
EMSIndication
Hypertension