NCT00473174

Brief 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. 1.the high prevalence of non-dipping among patients with essential hypertension
  2. 2.the need for a proper 24-hour BP control with particular emphasis on the regulation of nighttime resting BP mean
  3. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 2, 2009

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

May 11, 2007

Last Update Submit

September 1, 2009

Conditions

Hypertension

Keywords

RamiprilAmbulatory blood pressure monitoringChronotherapyCircadianNon-dipper

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the efficacy of bedtime administration of ramipril in subjects with essential hypertension by testing the hypothesis of superior nocturnal SBP lowering in ABPM measurements compared with ramipril administered on awakening

    Three months

Secondary Outcomes (5)

  • To demonstrate that ramipril at bedtime is more effective than ramipril upon awakening in terms of nocturnal DBP lowering in ABPM

    Three months

  • To demonstrate that ramipril at bedtime is not inferior to ramipril upon awakening in terms of 24-hour SBP/DBP lowering in ABPM

    Three months

  • To demonstrate that ramipril at bedtime is more effective than ramipril upon awakening in terms of increasing the diurnal/nocturnal SBP and DBP ratio determined by ABPM

    Three months

  • To demonstrate that ramipril at bedtime offers a similar safety profile than ramipril upon awakening

    Three months

  • To demonstrate that compliance with ramipril at bedtime is similar to compliance of ramipril upon awakening

    Three months

Study Arms (2)

1

ACTIVE COMPARATOR

Ramipril on awakening

Drug: RamiprilDevice: ambulatory blood pressure monitoring

2

ACTIVE COMPARATOR

Ramipril at bedtime

Drug: RamiprilDevice: ambulatory blood pressure monitoring

Interventions

RamiprilDRUG

Dosing on awakening versus bedtime

12
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

12

Eligibility Criteria

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

You may qualify if:

  • Essential hypertension

You may not qualify if:

  • Severe hypertension.
  • Secondary hypertension.
  • Grade III/IV hypertensive retinopathy.
  • Type 1 diabetes.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, 15701, Spain

Location

Related Publications (1)

  • Hermida RC, Ayala DE. Chronotherapy with the angiotensin-converting enzyme inhibitor ramipril in essential hypertension: improved blood pressure control with bedtime dosing. Hypertension. 2009 Jul;54(1):40-6. doi: 10.1161/HYPERTENSIONAHA.109.130203. Epub 2009 May 11.

    PMID: 19433778RESULT

MeSH Terms

Conditions

Hypertension

Interventions

RamiprilBlood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBlood Pressure DeterminationDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Ramon C Hermida, PhD

    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

May 11, 2007

First Posted

May 14, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 2, 2009

Record last verified: 2009-09

Locations

ES(1)