Combination drug treatment in moderate-to-severe essential hypertension

ISRCTN	ISRCTN46173989
DOI	https://doi.org/10.1186/ISRCTN46173989
Secondary identifying numbers	N0236066889

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Graham A MacGregor
Scientific

Blood Pressure Unit
Jenner Wing
St George's Hospital
Blackshaw Road, Tooting
London
SW17 0QT
United Kingdom

Phone	+44 (0)20 8725 2848
Email	g.macgregor@sghms.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Combination drug treatment in moderate-to-severe essential hypertension
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	moxonidine or doxazosin
Primary outcome measure	Control of blood pressure < 150/90 mmHg
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/1999
Completion date	30/09/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	20
Key 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)
Key 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.
Date of first enrolment	01/05/1999
Date of final enrolment	30/09/2005

Blood Pressure Unit

London
SW17 0QT
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

St George's Healthcare NHS Trust

No information available

The Blood Pressure Unit

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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