Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension. (OLINDA)

Brainfarma

Status and phase

Unknown

Phase 3

Conditions

Hypertension,Essential

Hypertension

Treatments

Drug: Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)

Drug: fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05110898

HYP 005-21

Details and patient eligibility

About

Phase III clinical trial, multicenter of non-inferiority, randomized, single-blind evaluation of fixed-dose combination of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.

Full description

This study is designed for the treatment of essential hypertension. It is performed in participants of both sexes, over 18 years of age, who have essential hypertension with diastolic blood pressure between 90 mmHg and 110 mmHg.

The rationale for studying the fixed dose combination is the possibility to enhance compliance and simplify treatment.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have signed the informed consent form;
Participants of both genders aged ≥ 18 years;
Essential hypertension based on a Diastolic Blood Pressure (DBP) > 90 mmHg and < 110 mmHg;
Patients with no treatment or on antihypertensive therapy taking up to two anti-hypertensives;
Possibility of discontinuing previous antihypertensive medication during the washout period.

Exclusion criteria

Essential hypertension based on a Diastolic Blood Pressure (DBP) ≥ 110mmHg and Systolic Blood Pressure (SBP) ≥ 180 mmHg;
Secondary hypertension;
Participants with Body Mass Index (BMI) > 35 Kg/m2;
Non-controlled types 1 and 2 diabetes mellitus (HbA1 > 8,5%);
Myocardial infarction, coronary surgery or coronary angioplasty with or without stent placement, in the last 6 months;
Unstable angina;
Participants with coronary heart disease taking beta-blockers;
Clinically manifest heart failure;
History of cardiac arrhythmia;
Moderate and severe heart valve disease;
Stroke or transient ischemic attack in the last 6 months;
Chronic disease of any nature that contraindicates the participant's participation according to the investigator's judgment, in particular renal failure with glomerular filtration rate < 45 ml/min, serum potassium levels ≥ 5,5 mEq/L or ≤ 3,5 mEq/L, hepatopathies, or SGOT, SGPT or bilirubin levels 3 times above the normal upper limit, and blood dyscrasias;
Known allergies or contraindication to the use of the study medication components;
Female participants who are pregnant, breastfeeding or who want to become pregnant;
COVID-19 symptoms;
Post COVID-19 syndrome with cardiovascular impairment;
Subjects who have participated in other study within the 12 months prior to screening (unless benefit is justified by the researcher).