NCT00302705

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 5, 2009

Status Verified

January 1, 2009

Enrollment Period

2.2 years

First QC Date

March 13, 2006

Last Update Submit

January 2, 2009

Conditions

Hypertension

Keywords

Ambulatory blood pressure monitoringValsartanEnalaprilMissing dose

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the efficacy of valsartan by testing the hypothesis of superior 24 hrs diastolic BP lowering after missing dose compared with enalapril.

    16 weeks

Secondary Outcomes (4)

  • To demonstrate that valsartan is more effective than enalapril in terms of systolic 24 hrs BP lowering after missing dose.

    16 weeks

  • To show that valsartan is more effective than enalapril in reducing systolic and diastolic BP in the time interval 20-24 hours after dose administration.

    16 weeks

  • To show that valsartan has a more favorable effect than enalapril in smoothness index and through/peak ratio.

    16 weeks

  • To demonstrate that valsartan offers better safety profile than enalapril.

    16 weeks

Study Arms (2)

Valsartan

ACTIVE COMPARATOR

160 mg/day on awakening

Drug: Valsartan, EnalaprilDevice: Ambulatory blood pressure monitoringProcedure: Missing one dose

Enalapril

ACTIVE COMPARATOR

10-20 mg/day on awakening

Drug: Valsartan, EnalaprilDevice: Ambulatory blood pressure monitoringProcedure: Missing one dose

Interventions

Valsartan, EnalaprilDRUG

160 mg valsartan versus 10-20 mg enalapril

EnalaprilValsartan
Ambulatory blood pressure monitoringDEVICE

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

EnalaprilValsartan
Missing one dosePROCEDURE

Patients skip the dose the second day of monitoring

EnalaprilValsartan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertension (grade 1-2)

You may not qualify if:

  • Severe hypertension
  • Secondary hypertension
  • Grade III/IV hypertensive retinopathy
  • Type 1 diabetes
  • Pregnant or lactating females
  • History of malignancy.
  • shift workers
  • intolerant to ABPM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Related Publications (1)

  • Hermida RC, Ayala DE, Khder Y, Calvo C. Ambulatory blood pressure-lowering effects of valsartan and enalapril after a missed dose in previously untreated patients with hypertension: a prospective, randomized, open-label, blinded end-point trial. Clin Ther. 2008 Jan;30(1):108-20. doi: 10.1016/j.clinthera.2008.01.012.

    PMID: 18343247DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanEnalaprilBlood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDipeptidesOligopeptidesPeptidesBlood Pressure DeterminationDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Ramon C Hermida, Ph.D.

    University of Vigo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 14, 2006

Study Start

January 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 5, 2009

Record last verified: 2009-01

Locations

ES(1)