|
Main
|
|
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. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000012669 |
|
Date of registration:
|
01/10/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management-
|
|
Scientific title:
|
Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- - Sildenafil for pulmonary arterial hypertension after pediatric cardiac surgery |
|
Date of first enrolment:
|
2010/10/01 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014811 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not applicable
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Nemoto, Shintaro |
|
Address:
|
2-7 Daigaku-machi, Takatsuki, Osaka
Japan |
|
Telephone:
|
072-683-1221 |
|
Email:
|
snemoto@poh.osaka-med.ac.jp |
|
Affiliation:
|
Osaka Medical College Hospital Department of Cardiovascular Surgery |
|
|
Name:
|
Shintaro Nemoto |
|
Address:
|
2-7 Daigaku-machi, Takatsuki, Osaka
Japan |
|
Telephone:
|
072-683-1221 |
|
Email:
|
snemoto@poh.osaka-med.ac.jp |
|
Affiliation:
|
Osaka Medical College Department of Thoracic and Cardiovascular Surgery |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: Patients with opened chest Patients with ventricular assist device Patients with extracorporeal membrane oxygenation Patients who are judged as inappropriate to include in this study. Patients with chronic lung disease, retinopathy, or gastrointestinal problems Patients who are received Nitrates or nitric oxide donors in non-intravenous form (oral, sublingual, buccal, transdermal, inhalation or aerosol) within 48 hours prior to receiving study drug treatment or intravenous forms within 2 hours prior to receiving study drug treatment (sildenafil is known to potentiate the hypotensive effects of nitrates; its concurrent use is contraindicated) Patients who are received endothelin antagonists(eg, bosentan) Patients who are received potent cytochrome P450 3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, and protease inhibitors) (Use of aprotinin will be allowed; aprotinin does not inhibit cytochrome P450 enzymes) Patients who are received ritonavir or nicorandil.
Age minimum:
Not applicable
Age maximum:
24months-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
pulmonary hypertension
|
|
Intervention(s)
|
|
Sildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat dose of sildenafil (0.5 or 1.0 mg/kg) can be given 4 hours after the initial administration by the investigators judgment. Sildenafil will be gradually weaned off for 5 to 7 days.
|
|
Primary Outcome(s)
|
|
Change in mean pulmonary arterial pressure after 4 hour administration from baseline
|
|
Secondary Outcome(s)
|
|
PAH crisis disappears Additional medication for PAH Successful wean from inhaled nitric oxide or other vasodilators Rebound PAH Duration of mechanical ventilation ICU stay
|
|
Source(s) of Monetary Support
|
|
Pfizer Inc.
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|