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

Launched by EMS · Jun 25, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different combinations of medications for treating high blood pressure, also known as essential hypertension. The goal is to see if one combination is just as good as the other in helping to lower blood pressure levels. The trial is not yet recruiting participants, but when it begins, it will be looking for adults aged 65 to 74 who have high blood pressure that is not well controlled with a single medication.

To be eligible for the study, participants need to agree to take part and must have been diagnosed with certain stages of high blood pressure that put them at higher risk for heart problems. However, there are several health conditions that would exclude someone from participating, such as having other serious diseases, extremely high blood pressure, or a history of severe heart or brain issues. Those who join the trial can expect to be monitored closely to see how well the medications work for them and to ensure their safety during the study.

Gender

ALL

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;