Contact information
Type
Scientific
Contact name
Dr S Mendis
ORCID ID
Contact details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
mendiss@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
RPC050
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Hypertension
Intervention
20 primary health care facilities.
10 facilities to apply the study protocol based on Scenario One of the WHO CVD-Risk Management Package (intervention sites).
Other 10 to continue with conventional treatment or usual care (control sites).
Intervention type
Other
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
07/05/2004
Overall study end date
07/05/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 30 - 70 years
2. Currently not under treatment for hypertension
3. Systolic blood pressure between 140 and 179 mmHg measured twice with a 5 to 10 minute interval
4. Informed consent given
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Pregnancy
2. Trauma (injury) as presenting complaint
3. Renal diseases: nephropathy, renal artery stenosis
4. Endocrinological (hormonal) disorders: phaechromocytoma, Cushing syndrome, Conn syndrome, acromegaly
5. Coarctation of the aorta
6. Use of steroids and/or non-steroidal anti-inflammatories (NSAIs)
7. All acute conditions presenting with bleeding, pain, diarrhoea, vomiting, breathing disorders and circulatory disorders
8. Inability to comply with the follow-up requirements
9. Inability to provide informed consent
Recruitment start date
07/05/2004
Recruitment end date
07/05/2005
Locations
Countries of recruitment
Sri Lanka, Switzerland
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)
Sponsor details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|