WithdrawnNCT02483936Updated Dec 8, 2025

Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control

A Phase 3 interventional study of Olmesartan medoxomil 40mg + chlorthalidone 12,5mg and Olmesartan medoxomil 40mg + chlorthalidone 25mg in Arterial Hypertension, sponsored by EMS. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Why this study was withdrawn

Decided by Sponsor

Phase: Phase 3
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

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.

Conditions studied

Arterial Hypertension

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Hypertension 6,689

In context

Hypertension

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

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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.

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 are being treated with monotherapy.

Exclusion criteria

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;

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: Olmesartan+Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
Experimental
Test 2: Olmesartan+Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.
Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg
Active comparator
Comparator 1: Benicar HCT®
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg
Active comparator
Comparator 2: Benicar HCT®
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.
Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg

Interventions

DrugOlmesartan medoxomil 40mg + chlorthalidone 12,5mg
1 tablet a day
DrugOlmesartan medoxomil 40mg + chlorthalidone 25mg
1 tablet a day
DrugOlmesartan 40mg + Hydrochlorothiazide 12,5mg
1 tablet a day
Also known as: Benicar HCT
DrugOlmesartan 40mg + Hydrochlorothiazide 25mg
1 tablet a day
Also known as: Benicar HCT

What researchers measure

Primary outcomes

Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
Time frame: 60 days

Secondary outcomes

Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time frame: 9 weeks

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02483936
Lead sponsor: EMS
Responsible party: Sponsor
First posted: Jun 29, 2015
Primary completion: Jun 1, 2025
Last update: Dec 8, 2025

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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