NCT01620788

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

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

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 636 (estimated)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Indapamide / Losartan	1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
DRUG	Indapamide / Losartan	1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day
DRUG	Hyzaar®	1 tablet of Hyzaar®, oral, a day
DRUG	Hyzaar®	1 tablet of Hyzaar®, oral, a day

Timeline

• Start date: 2019-11-27
• Primary completion: 2023-07-01
• Completion: 2023-10-01
• First posted: 2012-06-15
• Last updated: 2022-07-27

Locations

1 site across 1 country: Brazil