Condition category
Circulatory System
Date applied
06/06/2003
Date assigned
23/09/2003
Last edited
27/09/2007
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

Prof Kar Keung Cheng

ORCID ID

Contact details

Department of Public Health & Epidemiology
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
K.K.Cheng@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TONIC

Study hypothesis

Prevention of vascular disease. Based on a population approach to lowering blood pressure in normotensive individuals (i.e. systolic BP<140, diastolic <90) to prevent vascular disease in older individuals.

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

Cardiovascular disease

Intervention

Both intervention and control groups will be provided with a study medication pack, and asked to take one tablet each day. The intervention medication will contain 12.5 mg of hydrochlorothiazide, and the control group will be supplied with identical looking inactive placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Hydrochlorothiazide

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2003

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

The eligible population for this pilot will include men and women between the ages of 60 and 75 (inclusive) living in Guangzhou, who attend for an ongoing cohort study, and are found to be normotensive.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

People with existing vascular disease, clear indication or contra-indication for antihypertensive treatment and diuretics, and other chronic medical problems that would interfere with participation will be excluded.

Recruitment start date

01/07/2003

Recruitment end date

31/12/2003

Locations

Countries of recruitment

China

Trial participating centre

Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

The University of Birmingham, Birmingham (UK)

Sponsor details

Department of Public Health & Epidemiology
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
p.adab@bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Department of Public Health & Epidemiology, The University of Birmingham, Birmingham, UK

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