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

Phase 3

Suspended

• Conditions: Hypertension
• Interventions: Drug: Hyzaar®; Drug: Indapamide / Losartan

• Registration Number: NCT01620788
• Lead Sponsor: EMS

Brief 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.

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 Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Study Start: 2019-11-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27
• Primary Completion: 2023-07
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 636

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)	Hyzaar®	-
Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)	Hyzaar®	-
Indapamide 1.5mg / Losartan 50mg	Indapamide / Losartan	-
Indapamide 1.5mg / Losartan 100mg	Indapamide / Losartan	-

Primary Outcome Measures

Name	Time	Method
Changes in systemic blood pressure measurements after 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety Will be Evaluated by the Adverse Events Occurrences	12 weeks

Trial Locations

Locations (1)

Allergisa; 🇧🇷 Campinas, São Paulo, Brazil