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

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ClinicalTrials.gov Identifier: NCT02483936
Recruitment Status : Not yet recruiting
First Posted : June 29, 2015
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE June 29, 2015
Last Update Posted Date April 7, 2020
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study. [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal [ Time Frame: 60 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
Safety will be evaluated by the adverse events occurrences [ Time Frame: 9 weeks ]
Adverse events will be collected and followed in order to evaluate safety and tolerability
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arterial Hypertension
Intervention  ICMJE
  • Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
    1 tablet a day
  • Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg
    1 tablet a day
  • Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg
    1 tablet a day
    Other Name: Benicar HCT
  • Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg
    1 tablet a day
    Other Name: Benicar HCT
Study Arms  ICMJE
  • Experimental: Test 1: Olmesartan+Chlorthalidone
    The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.
    Intervention: Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
  • Experimental: Test 2: Olmesartan+Chlorthalidone
    The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.
    Intervention: Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg
  • Active Comparator: Comparator 1: Benicar HCT®
    The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
    Intervention: Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg
  • Active Comparator: Comparator 2: Benicar HCT®
    The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.
    Intervention: Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)
348
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2015)
110
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Monalisa F.B. Oliveira, M.D. 55 pesquisa.clinica@ems.com.br
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483936
Other Study ID Numbers  ICMJE OLCEMS0215
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMS
Study Sponsor  ICMJE EMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EMS
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP