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

NCT ID: NCT05110898

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-10-01

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.

Conditions

Hypertension; Hypertension,Essential

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fixed-dose Olmesartan 20mg/40 mg + Indapamide 1,5 mg

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Fixed-dose of Olmesartan 20mg or 40 mg + Indapamide 1,5 mg oral administration, once a day for 12 weeks. Initially, the participant will be treated with Olmesartan 20mg + Indapamide 1,5 mg. If after 6 weeks the diastolic blood pressure is above 90 mmHg, the dose will be changed to fixed dose of Olmesartan 40 mg + Indapamide 1,5 mg.

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg) oral administration, once a day for 12 weeks. Initially, the participant will be treated with Benicar® (olmesartan) 20mg and Natrilix® (indapamide) 1,5 mg. If after 6 weeks the diastolic blood pressure is above 90 mmHg, the dose of Benicar® (olmesartan) will be changed to 40 mg.

Interventions

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

Fixed-dose of Olmesartan 20mg or 40 mg + Indapamide 1,5 mg oral administration, once a day for 12 weeks. Initially, the participant will be treated with Olmesartan 20mg + Indapamide 1,5 mg. If after 6 weeks the diastolic blood pressure is above 90 mmHg, the dose will be changed to fixed dose of Olmesartan 40 mg + Indapamide 1,5 mg.

Intervention Type: DRUG

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) oral administration, once a day for 12 weeks. Initially, the participant will be treated with Benicar® (olmesartan) 20mg and Natrilix® (indapamide) 1,5 mg. If after 6 weeks the diastolic blood pressure is above 90 mmHg, the dose of Benicar® (olmesartan) will be changed to 40 mg.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainfarma Industria Química e Farmacêutica S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HYP 005-21

Identifier Type: -

Identifier Source: org_study_id