drugset / Trial / NCT00473174

Comparison of Awakening Versus Bedtime Dosing of Ramipril in Subjects With Essential Hypertension

NCT00473174

RandomizedParallel-groupOpen-labelTreatment

Summary

This prospective chronotherapy trial will investigate the potential differing efficacy of ramipril in doses from 5 to 10 mg/day when administered, as a monotherapy either upon awakening from nighttime sleep or at bedtime, to diurnally active patients with grade 1 or 2 essential hypertension, who will be evaluated by 48-hour ABPM before and after pharmacologic intervention. The benefits from this trial may be extremely important, taking into account 1. the high prevalence of non-dipping among patients with essential hypertension 2. the need for a proper 24-hour BP control with particular emphasis on the regulation of nighttime resting BP mean 3. the lacking information on the administration-time dependent effects on BP of ramipril, a widely used ACEI in doses of 5-10 mg/day.

Timeline

Start
2007-03
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ramipril Small molecule 5 mg
Comparator Ramipril Small molecule 10 mg