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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vigo
• Collaborator: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
• Treatments: Ramipril

Criteria

Inclusion Criteria:

• Essential hypertension

Exclusion Criteria:

• Severe hypertension.

• Secondary hypertension.

• Grade III/IV hypertensive retinopathy.

• Type 1 diabetes.

• Cerebrovascular or cardiovascular event during the last 12 months prior to inclusion.

• Pregnant or lactating females.

• History of malignancy within the past five years.

• Shift workers.

• Obstructive sleep apnea.

• Use of disallowed concomitant medication.

• Intolerant to ABPM.