Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0237101856
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to evaluate the impact on blood pressure control, patient satisfaction and well being and adherence to medication of conventional gradual titration of anti-hypertensive treatment versus rapid introduction and dose escalation of four anti-hypertensive agents in subjects with diabetic nephropathy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial, open design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Hypertension
Intervention
Standard versus rapid initiation of anti-hypertensive therapy
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Patient adherence to treatment
2. Blood pressure
3. Proteinuria
4. Adverse events
5. Treatment satisfaction
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2001
Overall trial end date
01/04/2004
Reason abandoned
Eligibility
Participant inclusion criteria
24 subjects recruited from new patients entering the nephropathy clinic
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
24
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2001
Recruitment end date
01/04/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diabetes Centre
Prescot
L35 5DR
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St Helens and Knowsley Hospitals NHS Trust (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