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WithdrawnNCT02521233Updated Jan 19, 2017

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

A Phase 3 interventional study of Candesartan + Chlorthalidone (8mg+12,5mg) and Candesartan + Chlorthalidone (8 mg + 25 mg) in Essential Arterial Hypertension, sponsored by EMS. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-19.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.

02

Conditions studied

  • Essential Arterial Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Test 1: Candesartan + Chlorthalidone

    The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 12,5 mg) a day, in the morning.

    Drug: Candesartan + Chlorthalidone (8mg+12,5mg)

  • Experimental
    Test 2: Candesartan + Chlorthalidone

    The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 25 mg) a day, in the morning.

    Drug: Candesartan + Chlorthalidone (8 mg + 25 mg)

  • Active comparator
    Comparator: losartan+hydrochlorothiazide (Hyzaar®)

    he patients will take 1 tablet (Losartan 50 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.

    Drug: losartan+hydrochlorothiazide

Interventions

  • DrugCandesartan + Chlorthalidone (8mg+12,5mg)

    Also known as: Candesartan + Chlorthalidone

  • DrugCandesartan + Chlorthalidone (8 mg + 25 mg)

    Also known as: Candesartan + Chlorthalidone

  • Druglosartan+hydrochlorothiazide

    Also known as: Hyzaar ®

06

What researchers measure

Primary outcomes

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

    Time frame: 60 days

Secondary outcomes

  1. Safety will be evaluated by the occurrences of adverse events.

    Time frame: 9 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02521233
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Aug 13, 2015
Start date
Nov 2016
Primary completion
May 2017 (estimated)
Completion
Aug 2017 (estimated)
Last update
Jan 19, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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