Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control

Essential Arterial Hypertension Clinical Trial

Official title:

Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02493322
• Other study ID #: OLCEMS0514OR-III
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2024
• Est. completion date: November 2026

Study information

• Verified date: February 2024
• Source: EMS
• Contact: Monalisa F.B. Oliveira, M.D.
• Phone: +551938879851
• 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: 261
• Est. completion date: November 2026
• Est. primary completion date: June 2026
• 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 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.

Related Conditions & MeSH terms

• Essential Arterial Hypertension
• Hypertension

Intervention

Drug:
• 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

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 occurrences of adverse events.		9 weeks