Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment
NCT ID: NCT01620788
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
636 participants
INTERVENTIONAL
2019-11-27
2023-10-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Indapamide 1.5mg / Losartan 50mg
Indapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
Indapamide 1.5mg / Losartan 100mg
Indapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day
Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)
Hyzaar®
1 tablet of Hyzaar®, oral, a day
Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)
Hyzaar®
1 tablet of Hyzaar®, oral, a day
Interventions
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Indapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
Indapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day
Hyzaar®
1 tablet of Hyzaar®, oral, a day
Hyzaar®
1 tablet of Hyzaar®, oral, a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* 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;
18 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Locations
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Allergisa
Campinas, São Paulo, Brazil
Countries
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Other Identifiers
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LIEMS1111
Identifier Type: -
Identifier Source: org_study_id
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