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

Phase 3

• Conditions: Hypertension,Essential; Hypertension
• Interventions: 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

• Registration Number: NCT05110898
• Lead Sponsor: Brainfarma Industria Química e Farmacêutica S/A

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-21
• Study Start: 2022-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)	Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)	-
Fixed-dose Olmesartan 20mg/40 mg + Indapamide 1,5 mg	fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg	-

Primary Outcome Measures

Name	Time	Method
Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.	12 weeks of treatment	To evaluate the non-inferiority of the fixed dose association of olmesartan + indapamide to the isolated drugs in the change of the diastolic blood pressure from baseline to 12 week endpoint through Ambulatory Blood Pressure Monitoring.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure Control	12 weeks of treatment	Proportion of participants achieving a diastolic blood pressure below 90 mmHg
Proportion of systolic and diastolic treatment response	12 weeks of treatment	Proportion of participants achieving a systolic blood pressure reduction greater than 20 mmHg and a diastolic blood pressure reduction greater than 10 mmHg.
Systolic Blood Pressure Control	12 weeks of treatment	Proportion of participants achieving a systolic blood pressure below 140 mmHg
Patients responses to the treatment satisfaction questionnaire	12 weeks of treatment	Patients responses to a questionnaire regarding if they are satisfied with the treatment.
Tolerability and occurrence of adverse events (AEs) during the study period.	12 weeks of treatment	Tolerability and occurrence of adverse events (AEs) during the study period in both study arms.
Systolic and diastolic blood pressure variation by ABPM exam	12 weeks of treatment	Systolic and diastolic blood pressure variation by ABPM examination from the baseline period compared to the result after 12 weeks of treatment;