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Trial record 20 of 134 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT02493322
Recruitment Status : Not yet recruiting
First Posted : July 9, 2015
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Essential Arterial Hypertension Drug: Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg Drug: Olmesartan medoxomil 20mg + Chlortalidone 25mg Drug: Olmesartan 20mg + hydrochlorothiazide 12,5mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 261 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 + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test 1: Olmesartan + Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Drug: Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg
1 tablet a day

Experimental: Test 2: Olmesartan + Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 25 mg) a day, in the morning.
Drug: Olmesartan medoxomil 20mg + Chlortalidone 25mg
1 tablet a day

Experimental: Comparator: Benicar HCT®
The patients will take 1 tablet (Olmesartan 20 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
Drug: Olmesartan 20mg + hydrochlorothiazide 12,5mg
1 tablet a day
Other Name: Benicar HCT®




Primary Outcome Measures :
  1. Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study. [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Safety will be evaluated by the occurrences of adverse events. [ Time Frame: 9 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493322


Contacts
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Contact: Monalisa F.B. Oliveira, M.D. +551938879851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02493322     History of Changes
Other Study ID Numbers: OLCEMS0514OR-III
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Chlorthalidone
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists