Randomised placebo controlled trial of antihypertensive agents for the prevention of cardiovascular complications of hypertension
| ISRCTN | ISRCTN13275753 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13275753 |
| Protocol serial number | N/A |
| Sponsor | Sponsor not defined - Record provided by the Medical Research Council (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 07/09/2005
- Registration date
- 08/09/2005
- Last edited
- 19/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Tom Meade
Scientific
Scientific
Non-communicable Disease Epidemiology Unit
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| tom.meade@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That treatment with diuretic or beta-blocker in hypertensive people aged between 65 and 74 reduces risk of stroke, coronary heart disease and death. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | Amiloride, hydrochlorothiazide compared with placebo; atenolol compared with placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amiloride, hydrochlorothiazide and atenolol |
| Primary outcome measure(s) |
Stroke, coronary events, deaths from all causes. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/1987 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 4396 |
| Key inclusion criteria | Men and women aged 65-74 at recruitment in 226 general practices in the Medical Research Council's General Practice Research Framework. Systolic blood pressure 160-209 mmHg and diastolic pressure less than 115 mmHg. |
| Key exclusion criteria | Secondary hypertension; already on antihypertensive treatment; accepted indication for antihypertensive treatment; myocardial infarction or stroke within previous three months; impaired renal function; presence of angina, intermittent claudication, diabetes, gout, bronchial asthma, serious intercurrent disease including malignant hypertension. |
| Date of first enrolment | 01/03/1982 |
| Date of final enrolment | 01/03/1987 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Non-communicable Disease Epidemiology Unit
London
WC1E 7HT
United Kingdom
WC1E 7HT
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/07/1985 | Yes | No |
