MedTrace Logo

Treatment of HYpertension: Morning Versus Evening

NCT02214498 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-08-15

No results posted yet for this study

Summary

Rationale:

The nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular disease (CVD) risk than either daytime office, awake or 24hour mean blood pressure. In general, when nocturnal blood pressure does not decline CVD risk is higher, usually referred to as "dippers" versus "non-dippers". Evening administration of treatment might lower nocturnal blood pressure more effectively than morning administration, which is most commonly advised.

The main hypothesis of this study is that evening administration of antihypertensive medication might resume the dipping pattern in non-dippers and as a consequence might reduce CVD risk more than morning administration.

Primary objective (in short):

-to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can resume a dipping blood pressure pattern in non-dippers

Study design: A double-blind placebo-controlled cross-over study Each person will use for one period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the evening, and one period of six weeks the other way around

Conditions

  • Essential Hypertension

Interventions

DRUG

Enalapril/hydrochlorothiazide

The intervention implies that morning and evening administration of enalapril/hydrochlorothiazide will be compared

DRUG

Placebo

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Jorie Versmissen, MD, PhD · Erasmus Medical Center

  • Teun Van Gelder, Prof · Erasmus Medical Center

  • Eric Sijbrands, Prof · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT02214498 on ClinicalTrials.gov