NCT02521233

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

August 10, 2015

Last Update Submit

January 17, 2017

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 occurrences of adverse events.

    9 weeks

Study Arms (3)

Test 1: Candesartan + Chlorthalidone

EXPERIMENTAL

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)

Test 2: Candesartan + Chlorthalidone

EXPERIMENTAL

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)

Comparator: losartan+hydrochlorothiazide (Hyzaar®)

ACTIVE COMPARATOR

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

Drug: losartan+hydrochlorothiazide

Interventions

Candesartan + Chlorthalidone (8mg+12,5mg)DRUG
Also known as: Candesartan + Chlorthalidone
Test 1: Candesartan + Chlorthalidone
Candesartan + Chlorthalidone (8 mg + 25 mg)DRUG
Also known as: Candesartan + Chlorthalidone
Test 2: Candesartan + Chlorthalidone
losartan+hydrochlorothiazideDRUG
Also known as: Hyzaar ®
Comparator: losartan+hydrochlorothiazide (Hyzaar®)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

candesartanChlorthalidonehydrochlorothiazide, losartan drug combination

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds
0

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