CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Eplerenone (Morning) +1 moredrug
Likely dose
Eplerenone (Morning) 50mgfrom 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/NCT00515021
NCT00515021Phase 4Completed

The Effects of Night-time Versus Morning Administration of Eplerenone on the Diurnal Variation of Plasminogen Activator Inhibitor-1

Vanderbilt University Medical Center·interventional·Posted Aug 13, 2007·Updated Feb 1, 2019

In Brief

A Phase 4 clinical trial evaluating Eplerenone (Morning) and Eplerenone (Night-time) for Metabolic Syndrome X. Completed, enrolled 21 participants across 1 site.

Detailed Summary

To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 13, 2007
Enrollment StartApr 1, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 18.9 years ago

Interventions

Eplerenone (Morning)drug

Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg. 100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks.

Eplerenone (Night-time)drug

Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg