Clinical Trial Results:
A Local, Multicentre, Open Label Access Study, To Provide Sildenafil citrate Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil citrate For Subjects In India
Summary
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EudraCT number |
2015-002238-37 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
26 Aug 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Mar 2016
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First version publication date |
16 Jul 2015
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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 |
A1481304
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01582438 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Jan 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Aug 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Aug 2014
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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 provide Sildenafil citrate therapy to the paediatric subjects who had completed Study A1481156 for the treatment of PAH in India and were judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil citrate citrate. The study medication was to be supplied as long as the Investigator felt that the subject continued to derive benefit from the treatment.
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Protection of trial subjects |
This study was designed and monitored in accordance with Pfizer's and the CRO’s standard operating procedures (SOPs), which comply with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Nov 2012
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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 |
India: 4
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Worldwide total number of subjects |
4
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EEA total number of subjects |
0
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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) |
2
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Adults (18-64 years) |
2
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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 |
- | ||||||
Pre-assignment
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Screening details |
Total 4 subjects were enrolled in single site in India. Subjects who had completed A1481156 were enrolled. | ||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Sildenafil citrate | ||||||
Arm description |
Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 months. | ||||||
Arm type |
Expanded access | ||||||
Investigational medicinal product name |
Sildenafil citrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Paediatric subjects were administered with Sildenafil citrate 20 milligram (mg) tablets for children with body weight greater than (>) 20 kilogram (kg), and 10 mg for children with body weight less than or equal to <=20 kg, thrice daily up to 21 months.
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Baseline characteristics reporting groups
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Reporting group title |
Sildenafil citrate
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Reporting group description |
Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 months. | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Sildenafil citrate
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Reporting group description |
Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 months. |
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End point title |
Subjects With Clinical Benefit on Usage of Continued Sildenafil Citrate [1] | ||||||||
End point description |
Sildenafil citrate therapy was provided to paediatric subjects for the treatment of PAH and were judged by the investigator to derive clinical benefit from continued treatment with the study drug. It was to be supplied for the treatment of PAH as long as the investigator felt that the subject continued to derive benefits from the treatment.
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End point type |
Primary
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End point timeframe |
Up to 21 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed for this study. |
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Notes [2] - No efficacy analysis was performed for this study. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to 21 months
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Adverse event reporting additional description |
Same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both the events. Version was not captured, here 0.0 is mentioned for dictionary version.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0.0
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Reporting groups
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Reporting group title |
Sildenafil citrate
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Reporting group description |
Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 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 |