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

NCT05110898 | Unknown Phase 3

• 1 other identifier: HYP 005-21
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/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.

Conditions

Hypertension; Hypertension,Essential

Keywords

olmesartan; olmesartan medoxomil; indapamide; hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks of treatment

Secondary Outcomes (6)

• Diastolic Blood Pressure Control

  12 weeks of treatment

• Systolic Blood Pressure Control

  12 weeks of treatment

• Proportion of systolic and diastolic treatment response

  12 weeks of treatment

• Systolic and diastolic blood pressure variation by ABPM exam

  12 weeks of treatment

• Patients responses to the treatment satisfaction questionnaire

  12 weeks of treatment

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

olmesartan; Indapamide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 8, 2021
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 21, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share