NCT01191450

Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension

A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.

Detailed description

To assess the efficacy and safety of the association of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Diupress® Eurofarma) in the treatment of elderly patients with arterial hypertension, compared to Chlorthalidone 25mg (Higroton® Laboratório Novartis) in same presentation form. Some eligibility criteria: perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram

Conditions

• Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Chlorthalidone 25 mg + amiloride hydrochloride 5 mg	Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
DRUG	Higroton® Laboratório Novartis	Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-08-30
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

10 sites across 1 country: Brazil