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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2014 |
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Main ID: |
EUCTR2010-021266-30-GB |
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Date of registration:
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04/10/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sildenafil Persistent Pulmonary Hypertension of the Newborn (PPHN) follow up study
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Scientific title:
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A FOLLOW UP INVESTIGATION FOR PATIENTS COMPLETING STUDY
A1481276 TO INVESTIGATE DEVELOPMENTAL PROGRESS 12 AND 24
MONTHS FOLLOWING COMPLETION OF SILDENAFIL TREATMENT |
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Date of first enrolment:
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14/12/2011 |
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Target sample size:
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40 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021266-30 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 E 42nd Street
NY 10017
New York
United States |
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Telephone:
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+18007181021 |
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Email:
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ClinicalTrials.govCallCenter@pfizer.com |
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Affiliation:
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Pfizer Inc |
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 E 42nd Street
NY 10017
New York
United States |
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Telephone:
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+18007181021 |
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Email:
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ClinicalTrials.govCallCenter@pfizer.com |
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Affiliation:
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Pfizer Inc |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Evidence of signed and dated informed consent document indicating that a legally acceptable guardian has been informed of all pertinent aspects of the study.
2. Any patient who received sildenafil treatment during study A1481276.
3. In the opinion of the investigator, the patient is considered appropriate for the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Not Applicable
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Persistent pulmonary hypertension of the newborn (PPHN)
MedDRA version: 16.1
Level: LLT
Classification code 10053592
Term: Newborn persistent pulmonary hypertension
System Organ Class: 100000004850
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Pharmaceutical Form:
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Physical examination (including neurological development assessment, opthalmology tests and behaviour), medical history including clinically relevant hospital admissions and medications at 1 and 2 years post sildenafil treatment in study A1481276.
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Secondary Objective: To collect 2 year survival data.
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Main Objective: To monitor the developmental progress of PPHN patients treated with sildenafil in study A1481276, 12 and 24 months after completion of sildenafil treatment.
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Primary end point(s): > Physical examination, to include neurological development assessment, hearing and ophthalmology tests.
> Medical history including clinically relevant hospital admissions in the 2 year follow up period.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1 and 2 years post sildenafil treatment in study A1481276
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Secondary end point(s): Survival to 2 years.
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Source(s) of Monetary Support
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Pfizer Inc., 235 East 42nd Street, New York, NY 10017
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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