Randomised placebo controlled trial of antihypertensive agents for the prevention of cardiovascular complications of hypertension

ISRCTN ISRCTN13275753
DOI https://doi.org/10.1186/ISRCTN13275753
Secondary identifying numbers N/A
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

Non-communicable Disease Epidemiology Unit
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Email tom.meade@lshtm.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThat 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) studiedHypertension
InterventionAmiloride, hydrochlorothiazide compared with placebo; atenolol compared with placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Amiloride, hydrochlorothiazide and atenolol
Primary outcome measureStroke, coronary events, deaths from all causes.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/1982
Completion date01/03/1987

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants4396 participants
Key inclusion criteriaMen 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 criteriaSecondary 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 enrolment01/03/1982
Date of final enrolment01/03/1987

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Non-communicable Disease Epidemiology Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Sponsor not defined - Record provided by the Medical Research Council (UK)
Not defined

20 Park Crescent
London
W1B 1AL
United Kingdom

Email tom.meade@lshtm.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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