Hypertension and coronary prevention research project
| ISRCTN | ISRCTN81113179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81113179 |
| Protocol serial number | N0544093603 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrookes |
- 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
Scientific
Box No 110
Department of Clinical Pharmacology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 762574 |
|---|---|
| mjb14@medschl.cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 08/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Box No 110
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
