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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Treatments: Indapamide; Olmesartan; Olmesartan Medoxomil

Criteria

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).