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

Sponsor
EMS (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT02483936
Collaborator
(none)
348
Enrollment
4
Arms
17.1
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
  • Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg
  • Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg
  • Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
348 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test 1: Olmesartan+Chlorthalidone

The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.

Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
1 tablet a day
Experimental: Test 2: Olmesartan+Chlorthalidone

The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.

Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg
1 tablet a day
Active Comparator: Comparator 1: Benicar HCT®

The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.

Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg
1 tablet a day
Other Names:
  • Benicar HCT

    		•
    Active Comparator: Comparator 2: Benicar HCT®

    The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.

    Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg
    1 tablet a day
    Other Names:
  • Benicar HCT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study. [60 days]

    Secondary Outcome Measures

    1. Safety will be evaluated by the adverse events occurrences [9 weeks]

      Adverse events will be collected and followed in order to evaluate safety and tolerability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • EMS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMS
    ClinicalTrials.gov Identifier:
    NCT02483936
    Other Study ID Numbers:
    • OLCEMS0215
    First Posted:
    Jun 29, 2015
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Hydrochlorothiazide
    Olmesartan
    Olmesartan Medoxomil
    Chlorthalidone

    Study Results

    No Results Posted as of Aug 5, 2022