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

NCT02521246 | Withdrawn Phase 3 DMC

• 1 other identifier: CACEMS0315
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Essential Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal

  60 days

Secondary Outcomes (1)

• Safety will be evaluated by the adverse events occurrences.

  9 weeks

Study Arms (3)

Test 1: Candesartan + Chlorthalidone

EXPERIMENTAL

The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 12,5 mg) a day, in the morning.

Drug: Candesartan + Chlorthalidone

Test 2: Candesartan + Chlorthalidone

EXPERIMENTAL

The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 25 mg) a day, in the morning.

Drug: Candesartan + Chlorthalidone

Comparator: Losartan+hydrochlorothiazide (Hyzaar®)

ACTIVE COMPARATOR

The patients will take 1 tablet (Losartan 100 mg + Hydrochlorothiazide 25 mg) a day, in the morning.

Drug: Losartan+hydrochlorothiazide

Interventions

Candesartan + Chlorthalidone DRUG

Test 1: Candesartan + Chlorthalidone

Losartan+hydrochlorothiazide DRUG

Also known as: Hyzaar ®

Comparator: Losartan+hydrochlorothiazide (Hyzaar®)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Interventions

candesartan; Chlorthalidone; hydrochlorothiazide, losartan drug combination

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01