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ISRCTN
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ISRCTN41186152
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ClinicalTrials.gov identifier
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Public title
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Randomised, placebo controlled study of the effect of sildenafil on hypoxia-induced pulmonary hypertension
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Scientific title
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Acronym
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N/A
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Serial number at source
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PG/02/024
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised placebo controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Hypoxia-induced pulmonary hypertension
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2001
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Anticipated end date
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31/12/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1. Placebo tds for 3 months
2. Sildenafil 25 mg tds for 3 months, or
3. Sildenafil 100 mg tds for 3 months
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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British Heart Foundation (UK)
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Trial website
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Publications
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Contact name
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Professor
MR
Wilkins
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Address
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Section on Clinical Pharmacology
Imperial College
Hammersmith Hospital
Du Cane Road
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City/town
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London
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Zip/Postcode
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W12 0NN
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Country
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United Kingdom
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Tel
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+44 (0)20 8383 2049
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Fax
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+44 (0)20 8383 2066
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Email
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m.wilkins@ic.ac.uk
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Sponsor
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British Heart Foundation (UK)
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Address
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14 Fitzhardinge Street
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City/town
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London
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Zip/Postcode
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W1H 6DH
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Country
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United Kingdom
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Tel
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+44 (0)20 7935 0185
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Fax
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+44 (0)20 7486 5820
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Email
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research@bhf.org.uk
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Sponsor website:
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http://www.bhf.org.uk/
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Date applied
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08/03/2002
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Last edited
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28/04/2008
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Date ISRCTN assigned
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08/03/2002
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