NCT02521246WithdrawnPhase 3
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
EMS0 sitesStarted: November 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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;
Arms & Interventions
Test 1: Candesartan + Chlorthalidone
Experimental
The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Intervention: Candesartan + Chlorthalidone (Drug)
Test 2: Candesartan + Chlorthalidone
Experimental
The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 25 mg) a day, in the morning.
Intervention: Candesartan + Chlorthalidone (Drug)
Comparator: Losartan+hydrochlorothiazide (Hyzaar®)
Active Comparator
The patients will take 1 tablet (Losartan 100 mg + Hydrochlorothiazide 25 mg) a day, in the morning.
Intervention: Losartan+hydrochlorothiazide (Drug)
Outcomes
Primary Outcomes
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
Time Frame: 60 days
Secondary Outcomes
- Safety will be evaluated by the adverse events occurrences.(9 weeks)
Investigators
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