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

Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02521233

Enrollment

Registered

2015-08-13

Start date

2016-11-30

Completion date

2017-08-31

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Arterial Hypertension

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.

Interventions

DRUGCandesartan + Chlorthalidone (8mg+12,5mg)

DRUGCandesartan + Chlorthalidone (8 mg + 25 mg)

DRUGlosartan+hydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal	60 days

Secondary

Measure	Time frame
Safety will be evaluated by the occurrences of adverse events.	9 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026