Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/03/2016
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

Dr Morris J Brown

ORCID ID

Contact details

Box No 110
Department of Clinical Pharmacology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 762574
mjb14@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544093603

Study information

Scientific title

Hypertension and coronary prevention research project

Acronym

Study hypothesis

Hypertension and coronary prevention research project

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

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/02/2001

Overall trial end date

08/02/2004

Reason abandoned

Eligibility

Participant inclusion criteria

700 Subjects (PROJ 08/01/2001).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/02/2001

Recruitment end date

08/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 110
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Other

Funder name

Cambridge Consortium - Addenbrookes

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

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