Comparison of the Antihypertensive Efficacy of Valsartan and Enalapril After Missing One Dose

NCT00302705 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-01-05

No results posted yet for this study

Summary

This study was designed in order to evaluate the blood pressure lowering effect of valsartan compared to enalapril over 24 hours after skipping one daily dose. Both drugs act on the renin-angiotensin-aldosterone system (RAAS) and are widely use for the treatment of hypertension. Previous studies had a significant limitation: the effect of a missing dose was not evaluated after the whole 24 hours post missing dose period (48 hours after last taken dose), and as a result, it does not imitate the real life situation of a missing dose.

Conditions

Interventions

DRUG

Valsartan, Enalapril

160 mg valsartan versus 10-20 mg enalapril

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

PROCEDURE

Missing one dose

Patients skip the dose the second day of monitoring

Sponsors & Collaborators

  • Hospital Clinico Universitario de Santiago

    collaborator OTHER
  • Novartis

    collaborator INDUSTRY
  • University of Vigo

    lead OTHER

Principal Investigators

  • Ramon C Hermida, Ph.D. · 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
2005-01-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Spain

Study Locations

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Entities

Companies

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 NCT00302705 on ClinicalTrials.gov