Contact information
Type
Scientific
Primary contact
Dr David Wald
ORCID ID
Contact details
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1 M6BQ
United Kingdom
d.s.wald@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P3/04/040
Study information
Scientific title
Acronym
CTBP (Combination Therapy Blood Pressure) Trial
Study hypothesis
Randomised, crossover trial to determine whether a beta blocker and an ACE inhibitor have independent effects in lowering blood pressure.
Ethics approval
East London Local Research Ethics Committee on 04/05/2004 (ref: DAI/MY/P304040)
Study design
Randomised, placebo-controlled, crossover trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular disease
Intervention
All participants received each of the following interventions:
1. Atenolol 25 mg
2. Lisinopril 5 mg
3. Atenolol 25 mg + lisinopril 5 mg
4. Placebo
sequentially in a random sequence.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Systolic and diastolic blood pressure.
Secondary outcome measures
Adverse effects.
Overall trial start date
14/04/2004
Overall trial end date
14/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men or women over age 40
2. Blood presssure over 100/60 mmHg
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Peripheral vascular disease
2. Asthma
3. Atrial Fibrillation (AF)
Recruitment start date
14/04/2004
Recruitment end date
14/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Institute of Preventive Medicine
London
EC1 M6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Charterhouse Square
London
EC1 M6BQ
United Kingdom
gerry.leonard@bartsandthelondon.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator-funded (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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19108791
Publication citations
-
Results
Wald DS, Law M, Mills S, Bestwick JP, Morris JK, Wald NJ, A 16-week, randomized, double-blind, placebo-controlled, crossover trial to quantify the combined effect of an angiotensin-converting enzyme inhibitor and a beta-blocker on blood pressure reduction., Clin Ther, 2008, 30, 11, 2030-2039, doi: 10.1016/j.clinthera.2008.11.003.