Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control

Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02483936
• Other study ID #: OLCEMS0215
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2024
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: EMS
• Contact: Monalisa F.B. Oliveira, M.D.
• Phone: 55
• Email: pesquisa.clinica[@]ems.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 348
• Est. completion date: September 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Drug:
• Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
1 tablet a day
• Olmesartan medoxomil 40mg + chlorthalidone 25mg
1 tablet a day
• Olmesartan 40mg + Hydrochlorothiazide 12,5mg
1 tablet a day
• Olmesartan 40mg + Hydrochlorothiazide 25mg
1 tablet a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.		60 days
Secondary	Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	9 weeks