Clinical Trial Results:
Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology
Summary
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EudraCT number |
2006-004705-26 |
Trial protocol |
GB |
Global end of trial date |
27 Feb 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jun 2020
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First version publication date |
06 Jun 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CRO529
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
South Kensington Campus, London, United Kingdom, SW7 2AZ
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Public contact |
PROFESSOR MICHAEL GATZOULIS, Imperial College London, +44 (0)20 7352 8121, m.gatzoulis@imperial.ac.uk
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Scientific contact |
PROFESSOR MICHAEL GATZOULIS, Imperial College London, +44 (0)20 7352 8121, m.gatzoulis@imperial.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Feb 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Feb 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Feb 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To examine safety and tolerability of oral sildenafil in patients with Eisenmenger physiology.
Primary endpoint:
Effects of sildenafil on systemic oxygen saturation in patients with pulmonary arterial hypertension related to Eisenmenger physiology
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients with Eisenmenger physiology (non-restrictive intra- or extra-cardiac communication with a right-to-left shunt at rest), in New York Heart Association (NYHA) class III and followed at a single tertiary center were recruited. Twelve patients with Eisenmenger physiology were recruited between April 2008 and February 2009. | ||||||
Pre-assignment
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Screening details |
All participants were admitted to the hospital for 2 days at the start of the study. Baseline assessment consisted of a QoL questionnaire, transthoracic echocardiogram, six-minute walk test (6MWT) and blood test. | ||||||
Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Open-label study
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Arms
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Arm title
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all patients | ||||||
Arm description |
All participants received Sildenafil for 3 months. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Sildenafil
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Investigational medicinal product code |
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Other name |
Revatio ® 20 mg film-coated tablets
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
20 mg three times daily for 3 months
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Baseline characteristics reporting groups
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Reporting group title |
Overall
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
all patients
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Reporting group description |
All participants received Sildenafil for 3 months. | ||
Subject analysis set title |
Baseline
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Baseline data of the participants
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End point title |
Oxygen saturation | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
3 months
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Statistical analysis title |
Oxigen saturation | ||||||||||||
Statistical analysis description |
Baseline compare to 3 months
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Comparison groups |
all patients v Baseline
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.76 | ||||||||||||
Method |
Fisher exact | ||||||||||||
Confidence interval |
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End point title |
Camphor scores Symptoms | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
3 months
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Statistical analysis title |
Symptome scores | ||||||||||||
Statistical analysis description |
Compare baseline to 3 months
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Comparison groups |
all patients v Baseline
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.002 | ||||||||||||
Method |
Fisher exact | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
3 months
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
all patients
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Reporting group description |
All participants received Sildenafil for 3 months. | ||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/20304507 |