Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Graham A MacGregor

ORCID ID

Contact details

Blood Pressure Unit
Jenner Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8725 2848
g.macgregor@sghms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236066889

Study information

Scientific title

Combination drug treatment in moderate-to-severe essential hypertension

Acronym

Study hypothesis

The aim of this study is to investigate the effect on blood pressure of the addition of moxonidine or doxazosin in 20 patients with moderate-to-severe essential hypertension who are not adequately controlled on triple therapy with amlodipine 5-10 mg once daily (o.d.), enalapril 10 mg b.d. and bendrofluazide 5 mg o.d.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hypertension

Intervention

Only those patients treated for at least one month with amlodipine 5-10mg o.d., enalapril 10-20mg twice daily (b.d.) and bendrofluazide 5mg o.d., will be included in the study if their supine systolic and/or diastolic BP is >160/90 mmHg on two different occasions. A randomised, double-blind, prospective study.

Intervention type

Drug

Phase

Not Specified

Drug names

moxonidine or doxazosin

Primary outcome measures

Control of blood pressure < 150/90 mmHg

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1999

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with uncomplicated, moderate-to-severe essential hypertension which is not adequately controlled on triple therapy with amlodipine 5-10 mg once daily (o.d.), enalapril 10-20 mg b.d. and bendrofluazide 5 mg o.d., iv)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Malignant or accelerated hypertension. Serum creatinine >60umol/L, ischaemic heart disease, cerebrovascular disease, impaired liver function, diabetes mellitus, pregnancy or risk of pregnancy, lactation, history of alcoholism, drug abuse or other problems likely to invalidate the informed consent.

Recruitment start date

01/05/1999

Recruitment end date

30/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Blood Pressure Unit
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

St George's Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Blood Pressure Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/10/2016: No publications found in PubMed, verifying study status with principal investigator.