MedTrace Logo

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

NCT00473174 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-09-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ramipril

Dosing on awakening versus bedtime

DEVICE

ambulatory blood pressure monitoring

Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours

Sponsors & Collaborators

  • King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • University of Vigo

    lead OTHER

Principal Investigators

  • Ramon C Hermida, PhD · University of Vigo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473174 on ClinicalTrials.gov