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Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02521246
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : August 13, 2015
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):

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: Candesartan + Chlorthalidone Drug: Losartan+hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 Candesartan Cilexetil + Chlorthalidone (16mg + 12.5mg and 16mg + 25mg) Compared With HYZAAR® in Hypertension Control
Study Start Date : November 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: Test 1: Candesartan + Chlorthalidone
The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Drug: Candesartan + Chlorthalidone
Experimental: Test 2: Candesartan + Chlorthalidone
The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 25 mg) a day, in the morning.
Drug: Candesartan + Chlorthalidone
Active Comparator: Comparator: Losartan+hydrochlorothiazide (Hyzaar®)
The patients will take 1 tablet (Losartan 100 mg + Hydrochlorothiazide 25 mg) a day, in the morning.
Drug: Losartan+hydrochlorothiazide
Other Name: Hyzaar ®

Primary Outcome Measures :
  1. Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal [ Time Frame: 60 days ]

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

Information from the National Library of Medicine

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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

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;
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Responsible Party: EMS Identifier: NCT02521246    
Other Study ID Numbers: CACEMS0315
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators