CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 246 enrolled
Drug / intervention
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg +1 moredrug
Likely dose
Chlorthalidone 25 mg + amiloride hydrochloride 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01191450
NCT01191450Phase 3Completed

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

Eurofarma Laboratorios S.A.·interventional·Posted Aug 30, 2010·Updated Jun 12, 2025

In Brief

A Phase 3 clinical trial evaluating Chlorthalidone 25 mg + amiloride hydrochloride 5 mg and Higroton® Laboratório Novartis for Arterial Hypertension. Completed, enrolled 246 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2010
Enrollment StartAug 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.8 years ago

Interventions

Chlorthalidone 25 mg + amiloride hydrochloride 5 mgdrug

Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks

Higroton® Laboratório Novartisdrug

Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks