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

NCT02483936 | Withdrawn Phase 3 DMC

• 1 other identifier: OLCEMS0215
• 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

Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.

  60 days

Secondary Outcomes (1)

• Safety will be evaluated by the adverse events occurrences

  9 weeks

Study Arms (4)

Test 1: Olmesartan+Chlorthalidone

EXPERIMENTAL

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

Test 2: Olmesartan+Chlorthalidone

EXPERIMENTAL

The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.

Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg

Comparator 1: Benicar HCT®

ACTIVE COMPARATOR

The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.

Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg

Comparator 2: Benicar HCT®

ACTIVE COMPARATOR

The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.

Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg

Interventions

Olmesartan medoxomil 40mg + chlorthalidone 12,5mg DRUG

1 tablet a day

Test 1: Olmesartan+Chlorthalidone

Olmesartan medoxomil 40mg + chlorthalidone 25mg DRUG

1 tablet a day

Test 2: Olmesartan+Chlorthalidone

Olmesartan 40mg + Hydrochlorothiazide 12,5mg DRUG

1 tablet a day

Also known as: Benicar HCT

Comparator 1: Benicar HCT®

Olmesartan 40mg + Hydrochlorothiazide 25mg DRUG

1 tablet a day

Also known as: Benicar HCT

Comparator 2: Benicar HCT®

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

Conditions

Hypertension

Interventions

Olmesartan Medoxomil; Chlorthalidone; olmesartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; 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; Chlorothiazide; Benzothiadiazines; Thiazides

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: June 25, 2015
• First Posted: June 29, 2015
• Primary Completion: June 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12