Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control
Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Arterial Hypertension
Intervention: Candesartan + Chlorthalidone (Drug); Candesartan + Chlorthalidone (Drug); Losartan+hydrochlorothiazide (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: EMS Overall contact:
Joyce M. Silva, M.D., Phone: +551938879851, Email: pesquisa.clinica@ems.com.br
Summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two
different drug associations in the essential hypertension control.
Clinical Details
Official title: Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan Cilexetil + Chlorthalidone (16mg + 12.5mg and 16mg + 25mg) Compared With HYZAAR® in Hypertension Control
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
Secondary outcome: Safety will be evaluated by the adverse events occurrences.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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;
Locations and Contacts
Joyce M. Silva, M.D., Phone: +551938879851, Email: pesquisa.clinica@ems.com.br Additional Information
Starting date: April 2016
Last updated: August 10, 2015
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