Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/09/2008
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 Ian B Wilkinson

ORCID ID

Contact details

Clinical Pharmacology Unit
Level 3
ACCI
Box 110
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 336806
ibw20@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544129338

Study information

Scientific title

Acronym

Study hypothesis

Does the selective phosphodiesterase-5 inhibitor tadalafil reduce arterial stiffness and blood pressure in systolic hypertension?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension

Intervention

The project will assess the effects of a single dose of the selective phosphodiesterase-5 inhibitor tadalafil on arterial stiffness and blood pressure in patients with systolic hypertension. Subjects will visit the Vascular Research Clinics for a screening visit and two study visits and will receive either placebo or tadalafil on each study visit. Measurements of blood pressure and arterial stiffness will be made at baseline and at hourly intervals for four hours following administration of the drug or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Tadalafil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/08/2003

Overall trial end date

10/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

15 subjects over 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

11/08/2003

Recruitment end date

10/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (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

Not published

Publication citations

Additional files

Editorial Notes