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

Primary Purpose

Hypertension, Hypertension,Essential

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg
Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)
Sponsored by
Brainfarma Industria Química e Farmacêutica S/A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring olmesartan, olmesartan medoxomil, indapamide, hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

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

    Arm Description

    Outcomes

    Primary Outcome Measures

    Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.
    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

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

    Full Information

    First Posted
    October 15, 2021
    Last Updated
    March 17, 2022
    Sponsor
    Brainfarma Industria Química e Farmacêutica S/A
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05110898
    Brief Title
    Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.
    Acronym
    OLINDA
    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

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Brainfarma Industria Química e Farmacêutica S/A

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Hypertension,Essential
    Keywords
    olmesartan, olmesartan medoxomil, indapamide, hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fixed-dose Olmesartan 20mg/40 mg + Indapamide 1,5 mg
    Arm Type
    Experimental
    Arm Title
    Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg
    Intervention Description
    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
    Intervention Name(s)
    Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.
    Description
    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.
    Time Frame
    12 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Diastolic Blood Pressure Control
    Description
    Proportion of participants achieving a diastolic blood pressure below 90 mmHg
    Time Frame
    12 weeks of treatment
    Title
    Systolic Blood Pressure Control
    Description
    Proportion of participants achieving a systolic blood pressure below 140 mmHg
    Time Frame
    12 weeks of treatment
    Title
    Proportion of systolic and diastolic treatment response
    Description
    Proportion of participants achieving a systolic blood pressure reduction greater than 20 mmHg and a diastolic blood pressure reduction greater than 10 mmHg.
    Time Frame
    12 weeks of treatment
    Title
    Systolic and diastolic blood pressure variation by ABPM exam
    Description
    Systolic and diastolic blood pressure variation by ABPM examination from the baseline period compared to the result after 12 weeks of treatment;
    Time Frame
    12 weeks of treatment
    Title
    Patients responses to the treatment satisfaction questionnaire
    Description
    Patients responses to a questionnaire regarding if they are satisfied with the treatment.
    Time Frame
    12 weeks of treatment
    Title
    Tolerability and occurrence of adverse events (AEs) during the study period.
    Description
    Tolerability and occurrence of adverse events (AEs) during the study period in both study arms.
    Time Frame
    12 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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