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NCT02493322 | NOT YET RECRUITING | Essential Arterial Hypertension

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

EMS

Brief Summary:

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

Condition or disease

Essential Arterial Hypertension

Intervention/treatment

Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg

Olmesartan medoxomil 20mg + Chlortalidone 25mg

Olmesartan 20mg + hydrochlorothiazide 12,5mg

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 261 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control

Location Details

NCT02493322

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How to Participate

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Locations

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