Condition category
Circulatory System
Date applied
02/03/2007
Date assigned
16/05/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes