Objective: to access pharmacokinetic profile of Sildenafil in long-term therapy of pediatric Pulmonary arterial hypertension (PAH). Thirty patients with PAH who refer to the pediatric heart clinic in Sari will be included. Inclusion criteria: 1) patients aged 1 month to 12 year. 2) mean pulmonary artery pressure of ≥ 25 mm Hg and a normal pulmonary capillary wedge pressure (PCWP). Exclusion criteria: 1) using other vasodilators such as epoprostanol, bosentan. 2) patients with systemic blood pressure <50% for the same age. The treatment duration is 16 weeks. Echocardiography is considered for all of patients before and 1 to 4 month after the beginning of therapy to determine related indexes. The initial dose is 0.5 mg/kg every 12 hours and can be increase up to 1 mg/kg every 6 hours. A serum sample is obtained when the clinical response appears. Serial samples are collected from 10 cases at 0.5, 1, 2, 4 h after using drug and just before the next dose.
General information
Acronym
SPPPH
IRCT registration information
IRCT registration number:IRCT138805222342N1
Registration date:2009-10-09, 1388/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-10-09, 1388/07/17
Registrant information
Name
Mohammad Reza Rafati
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
mrrafati@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences (Vice-Chancellor for research)
Expected recruitment start date
2009-09-02, 1388/06/11
Expected recruitment end date
2010-03-01, 1388/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Sildenafil Pharmacokinetic Properties in Long-term Treatment of Pediatrics Pulmonary Hypertension
Public title
Evaluation of Sildenafil in Treatment of Pediatrics Pulmonary Hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) patients aged 1 month to 12 year 2) mean pulmonary artery pressure of ≥ 25 mm Hg and a normal pulmonary capillary wedge pressure (PCWP). Exclusion criteria: 1) using other vasodilators such as epoprostanol, bosentan 2) patients with systemic blood pressure <50% for the same age
Age
From 1 year old to 12 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor of Research, Mazandaran university of medical sciences
Street address
Moallem square
City
Sari
Postal code
4817844718
Approval date
2009-06-24, 1388/04/03
Ethics committee reference number
44-88
Health conditions studied
1
Description of health condition studied
pediatric pulmonary hypertension
ICD-10 code
127.0
ICD-10 code description
Primary pulmonary hypertension
Primary outcomes
1
Description
Reduction of pulmonary hypertension
Timepoint
1 month
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Adverse drug reactions
Timepoint
1 month
Method of measurement
Question and exam
Intervention groups
1
Description
only intervention group, it bigins 0.5 mg/kg q12 hr and can increase up to 1 mg/kg q6hr weekly.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali hospital
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice-Chancellor of Research (Dr. Seid Jalal Hosseinimehr)
Street address
Moallem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Arash Badiee
Position
Pharmacy student
Other areas of specialty/work
Street address
Boali hospital
City
Sari
Postal code
Phone
+98 15 1223 3014
Fax
Email
amir11aina@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Raza Rafati
Position
Clinical pharmacy specialist
Other areas of specialty/work
Street address
Boali hospital
City
Sari
Postal code
Phone
+98 15 1223 3014
Fax
Email
mrrafati@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)