Trial of the Effect of Thiazides on Normotensive Individuals in China
| ISRCTN | ISRCTN21115645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21115645 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/06/2003
- Registration date
- 23/09/2003
- Last edited
- 17/04/2023
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Prof Kar Keung Cheng
Scientific
Scientific
Department of Public Health & Epidemiology
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| K.K.Cheng@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Hydrochlorothiazide |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2003 |
| Completion date | 31/12/2003 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Total final enrolment | 0 |
| 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 |
Locations
Countries of recruitment
- China
- England
- United Kingdom
Study participating centre
Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
The University of Birmingham, Birmingham (UK)
University/education
University/education
Department of Public Health & Epidemiology
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| p.adab@bham.ac.uk | |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
University/education
Department of Public Health & Epidemiology, The University of Birmingham, Birmingham, UK
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
17/04/2023: The trial was abandoned before ethics approval was sought.
