Trial of the Effect of Thiazides on Normotensive Individuals in China

ISRCTN	ISRCTN21115645
DOI	https://doi.org/10.1186/ISRCTN21115645
Protocol serial number	N/A
Sponsor	The University of Birmingham, Birmingham (UK)
Funder	Department of Public Health & Epidemiology, The University of Birmingham, Birmingham, UK

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

Prof Kar Keung Cheng
Scientific

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

Email	K.K.Cheng@bham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Trial of the Effect of Thiazides on Normotensive Individuals in China
Study acronym	TONIC
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hydrochlorothiazide
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003
Reason abandoned (if study stopped)	Objectives no longer viable

Participant type(s)	Patient
Age group	Senior
Sex	All
Key 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.
Key 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.
Date of first enrolment	01/07/2003
Date of final enrolment	31/12/2003

Department of Public Health & Epidemiology

Birmingham
B15 2TT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

17/04/2023: The trial was abandoned before ethics approval was sought.