Condition category
Circulatory System
Date applied
08/03/2002
Date assigned
08/03/2002
Last edited
06/01/2011
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

Professor MR Wilkins

ORCID ID

Contact details

Section on Clinical Pharmacology
Imperial College
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)20 8383 2049
m.wilkins@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PG/02/024

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Hypoxia-induced pulmonary hypertension

Intervention

1. Placebo tds for 3 months
2. Sildenafil 25 mg tds for 3 months, or
3. Sildenafil 100 mg tds for 3 months

Intervention type

Drug

Phase

Not Specified

Drug names

sildenafil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2001

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males or females aged 18 years and over
2. Resting pulmonary artery pressure ≥25 mmHg
3. Written informed consent must be obtained by the investigator before the subject is screened for the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2001

Recruitment end date

31/12/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section on Clinical Pharmacology
London
W12 0NN
United Kingdom

Sponsor information

Organisation

British Heart Foundation (UK)

Sponsor details

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk

Sponsor type

Charity

Website

http://www.bhf.org.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11468204

Publication citations

  1. Results

    Zhao L, Mason NA, Morrell NW, Kojonazarov B, Sadykov A, Maripov A, Mirrakhimov MM, Aldashev A, Wilkins MR, Sildenafil inhibits hypoxia-induced pulmonary hypertension., Circulation, 2001, 104, 4, 424-428.

Additional files

Editorial Notes