NCT01669928

Brief Summary

A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control. To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Apr 2012

Typical duration for phase_4 hypertension

Geographic Reach
2 countries

2 active sites

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

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

March 8, 2021

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

July 2, 2012

Results QC Date

April 29, 2019

Last Update Submit

March 5, 2021

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in 24 Hour Systolic Blood Pressure

    Changes in 24 hour systolic Blood Pressure using ABPM

    6 months

Secondary Outcomes (8)

  • Mean Day-time ABPM Systolic BP

    6 months

  • Mean Day-time ABPM Diastolic BP

    6 months

  • Μean Night Time ABPM Systolic BP

    6 months

  • Μean Night Time ABPM Diastolic BP

    6 months

  • Mean Clinic - Systolic BP

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Evening medication

ACTIVE COMPARATOR

Anti hypertensive medication in the evening (between 18.00 and 23.00)

Drug: Anti-hypertensive Medication -

Morning medication

ACTIVE COMPARATOR

Antihypertensive medication in the morning(between 06.00 and 11.00)

Drug: Anti-hypertensive Medication -

Interventions

Anti-hypertensive Medication -DRUG

Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication. Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).

Also known as: PR1 Diruetics, PR3 Beta Blockers, PR4 Calcium channel blockers, PR5 ACE inhibitors, PR6 Angiotensin II Receptor Blockers, PR7 Centrally acting agents, PR8 Alpha blockers, PR9 Direct Renin Inhibitors, PR10 Vasodilators
Evening medicationMorning medication

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian patients aged 18-80 years;
  • History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months.

You may not qualify if:

  • BP levels \> 150/90 mmHg or \< 115/75 mmHg in the last 3 months.
  • Postural hypotension, defined as symptoms resulting from a \> 20 mm Hg drop of systolic BP or a \> 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position.
  • Known Extreme dippers at baseline (fall of mean night time SBP \> 20% of mean day time SBP)
  • Individuals with jobs which require night-time shift work.
  • Pregnant women or those planning to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Imperial Clinical Trials Unit

London, W2 1LA, United Kingdom

Location

Related Publications (8)

  • Lemmer B. Clinical chronopharmacology: the importance of time in drug treatment. Ciba Found Symp. 1995;183:235-47; discussion 247-53. doi: 10.1002/9780470514597.ch13.

    PMID: 7656688BACKGROUND

  • Bruguerolle B. Chronopharmacokinetics. Current status. Clin Pharmacokinet. 1998 Aug;35(2):83-94. doi: 10.2165/00003088-199835020-00001.

    PMID: 9739478BACKGROUND

  • Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.

    PMID: 20226988BACKGROUND

  • Smolensky MH, Hermida RC, Ayala DE, Tiseo R, Portaluppi F. Administration-time-dependent effects of blood pressure-lowering medications: basis for the chronotherapy of hypertension. Blood Press Monit. 2010 Aug;15(4):173-80. doi: 10.1097/MBP.0b013e32833c7308.

    PMID: 20571367BACKGROUND

  • Hermida RC, Ayala DE, Mojon A, Fernandez JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 2010 Sep;27(8):1629-51. doi: 10.3109/07420528.2010.510230.

    PMID: 20854139BACKGROUND

  • Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301.

    PMID: 10639539BACKGROUND

  • Mayet J, Chapman N, Li CK, Shahi M, Poulter NR, Sever PS, Foale RA, Thom SA. Ethnic differences in the hypertensive heart and 24-hour blood pressure profile. Hypertension. 1998 May;31(5):1190-4. doi: 10.1161/01.hyp.31.5.1190.

    PMID: 9576134BACKGROUND

  • Poulter NR, Savopoulos C, Anjum A, Apostolopoulou M, Chapman N, Cross M, Falaschetti E, Fotiadis S, James RM, Kanellos I, Szigeti M, Thom S, Sever P, Thompson D, Hatzitolios AI. Randomized Crossover Trial of the Impact of Morning or Evening Dosing of Antihypertensive Agents on 24-Hour Ambulatory Blood Pressure. Hypertension. 2018 Oct;72(4):870-873. doi: 10.1161/HYPERTENSIONAHA.118.11101.

    PMID: 30354703DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Professor Neil Poulter
Organization
Imperial College London
n.poulter@imperial.ac.uk
+44 20 7594 3446

Study Officials

  • Neil Poulter, MRCS LRCP MBBS MRCP MSc FRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

August 21, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 8, 2021

Results First Posted

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)GR(1)