HypertensionPhase 3NCT01620788

Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment

A Phase 3 study testing Indapamide / Losartan and Hyzaar® in people with Hypertension, run by EMS at 1 site in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Trial summary

The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Indapamide / Losartan and Hyzaar®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 636 participants
Where: 1 siteBrazil
Study dates: 27 Nov 2019to 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

Adults male or female aged ≥ 18 years old;
Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,
Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,
Patient who accept the discontinuation of previous hypertension therapy.

Who cannot join

Patients with blood pressure ≥ 180/100 mmHg;
Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics;
Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dL);
Patients with hypo or hyperkalemia (serum potassium outside normal range);
Patients with ALT greater than 2.5 the upper limit of normal or active liver disease;
Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period;

Show all 12Show fewer

Patients on drug or alcohol abuse in the last two years;
Patients with secondary hypertension (renovascular disease, pheochromocytoma, Cushing's syndrome);
Patients with allergic reactions or hypersensitivity to ACE inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation;
Refusal or inability to provide the Informed Consent Term.;
Refusal to discontinue the anti-hypertensive medication.
Patients at the discretion of the investigator does not have indication for discontinuing the current medications;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Allergisa
Campinas, São Paulo

Other trials in Brazil

About this study

Official title: Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension

The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.

Read the detailed description

open label,randomized, multicenter
Experiment duration: 12 weeks.
05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization).
evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the Hyzaar® in patients with hypertension
Adverse events evaluation

Conditions: Hypertension
Being tested: Indapamide / Losartan, Hyzaar®
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Indapamide / LosartanDrug
Also called Indapamide 1.5mg / Losartan 50mg
1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
Indapamide / LosartanDrug
Also called Indapamide 1.5mg / Losartan 100mg
1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day
Hyzaar®Drug
Also called Losartan 50mg/Hydrochlorothiazide12,5mg
1 tablet of Hyzaar®, oral, a day
Hyzaar®Drug
Also called Losartan 100mg/Hydrochlorothiazide 25mg
1 tablet of Hyzaar®, oral, a day

Study groups in NCT01620788
Study group	Role	What they receive
Indapamide 1.5mg / Losartan 50mg	Experimental	Not described Receives: Drug: Indapamide / Losartan
Indapamide 1.5mg / Losartan 100mg	Experimental	Not described Receives: Drug: Indapamide / Losartan
Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)	Active comparator	Not described Receives: Drug: Hyzaar®
Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)	Active comparator	Not described Receives: Drug: Hyzaar®

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in systemic blood pressure measurements after 12 weeks
Measured: 12 weeks

Secondary outcomes (1)

Safety Will be Evaluated by the Adverse Events Occurrences
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 2019Oct 2023

First posted15 Jun 2012 (estimated)
Study start27 Nov 2019
Primary completionJul 2023 (estimated)
Study completionOct 2023 (estimated)

Why it stopped: Substancial amendment

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.
More trials run by EMSThe sponsor's other registered studies.
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: None (open label)
Enrolment: 636 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01620788
Sponsor's protocol ID: LIEMS1111
Status last verified: Jul 2022
First submitted: 29 May 2012
Last updated: 27 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension
ClinicalTrials.gov ID: NCT01620788
Acronym / sponsor ID: LIEMS1111
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: SuspendedReason stopped: Substancial amendment
Enrolment: 636 participants (estimated)
Lead sponsor: EMSIndustry (pharma, biotech, devices)
Study start: 27 Nov 2019 (actual)
Primary completion: Jul 2023 (estimated)
Study completion: Oct 2023 (estimated)
First posted: 15 Jun 2012 (estimated)
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.

The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.

Detailed description

open label,randomized, multicenter
Experiment duration: 12 weeks.
05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization).
evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the Hyzaar® in patients with hypertension
Adverse events evaluation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Indapamide 1.5mg / Losartan 50mg	Experimental	Drug: Indapamide / Losartan
Indapamide 1.5mg / Losartan 100mg	Experimental	Drug: Indapamide / Losartan
Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)	Active comparator	Drug: Hyzaar®
Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)	Active comparator	Drug: Hyzaar®

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults male or female aged ≥ 18 years old;
Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,
Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,
Patient who accept the discontinuation of previous hypertension therapy.

Key exclusion criteria (12 listed)

Patients with blood pressure ≥ 180/100 mmHg;
Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics;
Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dL);
Patients with hypo or hyperkalemia (serum potassium outside normal range);
Patients with ALT greater than 2.5 the upper limit of normal or active liver disease;

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
Indapamide / LosartanAlso: Indapamide 1.5mg / Losartan 50mg1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day	Drug	Indapamide 1.5mg / Losartan 50mg
Indapamide / LosartanAlso: Indapamide 1.5mg / Losartan 100mg1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day	Drug	Indapamide 1.5mg / Losartan 100mg
Hyzaar®Also: Losartan 50mg/Hydrochlorothiazide12,5mg1 tablet of Hyzaar®, oral, a day	Drug	Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)
Hyzaar®Also: Losartan 100mg/Hydrochlorothiazide 25mg1 tablet of Hyzaar®, oral, a day	Drug	Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)

Primary outcome

Changes in systemic blood pressure measurements after 12 weeks
Time frame: 12 weeks

1 secondary outcome

Safety Will be Evaluated by the Adverse Events Occurrences
Time frame: 12 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indapamide / Losartan and Hyzaar® in people with Hypertension, run by EMS at 1 site in Brazil.

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 4 inclusion and 12 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: paused, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Changes in systemic blood pressure measurements after 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01620788.

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 27 Jul 2022.