HypertensionPhase 3OLINDANCT05110898
Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.
A Phase 3 study testing fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg and Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg) in people with Hypertension and Hypertension,Essential, run by Brainfarma Industria Química e Farmacêutica S/A.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Hypertension,Essential
- What is being tested?
- fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg and Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
About this study
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.
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.
Read the 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
- Being tested
- fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg, Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)
- Keywords
- olmesartan, olmesartan medoxomil, indapamide, hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mgDrug
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed-dose Olmesartan 20mg/40 mg + Indapamide 1,5 mg | Experimental | Not described Receives: 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 | Not described Receives: Drug: Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks of treatment
Secondary outcomes (6)
Diastolic Blood Pressure Control
Proportion of participants achieving a diastolic blood pressure below 90 mmHg
Measured: 12 weeks of treatment
Systolic Blood Pressure Control
Proportion of participants achieving a systolic blood pressure below 140 mmHg
Measured: 12 weeks of treatment
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.
Measured: 12 weeks of treatment
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;
Measured: 12 weeks of treatment
Patients responses to the treatment satisfaction questionnaire
Patients responses to a questionnaire regarding if they are satisfied with the treatment.
Measured: 12 weeks of 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.
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110898
- Sponsor's protocol ID
- HYP 005-21
- Acronym
- OLINDA
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05110898
- Acronym / sponsor ID
- OLINDA / HYP 005-21
- Conditions
- Hypertension, Hypertension,Essential
- Keywords
- olmesartan, olmesartan medoxomil, indapamide, hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mgFixed-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. | Drug | Fixed-dose Olmesartan 20mg/40 mg + Indapamide 1,5 mg |
| 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. | Drug | Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg) |
Primary outcome
Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.
Time frame: 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.
6 secondary outcomes
Diastolic Blood Pressure Control
Time frame: 12 weeks of treatment
Systolic Blood Pressure Control
Time frame: 12 weeks of treatment
Proportion of systolic and diastolic treatment response
Time frame: 12 weeks of treatment
Systolic and diastolic blood pressure variation by ABPM exam
Time frame: 12 weeks of treatment
Patients responses to the treatment satisfaction questionnaire
Time frame: 12 weeks of treatment
Tolerability and occurrence of adverse events (AEs) during the study period.
Time frame: 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg and Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg) in people with Hypertension and Hypertension,Essential, run by Brainfarma Industria Química e Farmacêutica S/A.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension. (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.