Clinical trial NCT05110898: Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.
Official title: Randomized, Single-Blind, Multicenter, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Hypertension,Essential
Keywords: olmesartan
olmesartan medoxomil
indapamide
hypertension
Lead sponsor: Brainfarma Industria Química e Farmacêutica S/A
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Diastolic Blood Pressure Control
timeFrame: 12 weeks of treatment
measure: Systolic Blood Pressure Control
timeFrame: 12 weeks of treatment
measure: Proportion of systolic and diastolic treatment response
timeFrame: 12 weeks of treatment
measure: Systolic and diastolic blood pressure variation by ABPM exam
timeFrame: 12 weeks of treatment
measure: Patients responses to the treatment satisfaction questionnaire
timeFrame: 12 weeks of treatment
measure: Tolerability and occurrence of adverse events (AEs) during the study period.
timeFrame: 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
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