Hypertension and coronary prevention research project

ISRCTN	ISRCTN81113179
DOI	https://doi.org/10.1186/ISRCTN81113179
Secondary identifying numbers	N0544093603

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 25/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

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

Contact information

Dr Morris J Brown
Scientific

Box No 110
Department of Clinical Pharmacology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 762574
Email	mjb14@medschl.cam.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title	Hypertension and coronary prevention research project
Study objectives	Hypertension and coronary prevention research project
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Hypertension
Intervention	It is important to state that this project was originally given approval by the ethics committee at the outset in 1986. It is ongoing, recruitment was less than originally intended, we wish to extend the period of follow-up from 15 years to an indefinite period for those patients who give their consent. Most formal outcome studies in hypertension last for a maximum of 5 years. By following a smaller number of patients over a longer period, we shall accumulate the necessary number of patient-years to detect any differences between treatment and answer some of the concerns about long-term efficacy and safety. The objectives of the hypertension and coronary research project are: 1. To determine whether 15 years of treatment of mild hypertension can reduce the incidence of myocardial infarction 2. To determine which antihypertensive drug is most effective at preventing the complications of hypertension 3. To determine which parameters among both associated risk factors for cardiovascular disease and possible aetiological factors for the development of hypertension can be used to predict whether and which antihypertensive treatment is indicated. Patients are randomised to one of the main classes of antihypertensive drugs and seen at monthly intervals until the blood pressure in controlled, then 2-yearly. The end points of myocardial infarction, stroke and death are captured at either of these visits or by tagging of the GP and hospital records. The study is conducted in accordance with ICH GCP.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	08/02/2001
Completion date	08/02/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	700
Key inclusion criteria	700 Subjects (PROJ 08/01/2001).
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	08/02/2001
Date of final enrolment	08/02/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Box No 110

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Other

Cambridge Consortium - Addenbrookes

No information available

Results and Publications

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

Editorial Notes

25/04/2018: No publications found, study status unverified
04/03/2016: No publications found, verifying study status with principal investigator.