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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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