Overview

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.