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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01620788
• Other study ID #: LIEMS1111
• Status: Suspended
• Phase: Phase 3
• Start date: November 27, 2019
• Est. completion date: October 2023

Study information

• Verified date: July 2022
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 636
• Est. completion date: October 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in systemic blood pressure measurements after 12 weeks		12 weeks
Secondary	Safety Will be Evaluated by the Adverse Events Occurrences		12 weeks