Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01642407 |
Recruitment Status :
Completed
First Posted : July 17, 2012
Results First Posted : April 4, 2017
Last Update Posted : February 1, 2021
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Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Pulmonary Arterial Hypertension Hypertension, Pulmonary |
Intervention |
Drug: Sildenafil |
Enrollment | 6 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | The study was conducted at 3 sites in Japan. Data reported is based on data cut-off date of 26 December 2016. |
Arm/Group Title | Sildenafil |
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Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Weeks 4, 8, and 16 in Part 1 of the study. Participants who completed Part 1 and required continuing treatment with Sildenafil, received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Weeks 28, 40, 52 and thereafter every 12 weeks until Sildenafil obtained marketing approval (up to a maximum of 119.6 weeks). Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets. |
Period Title: Part 1 (Screening Till Week 16) | |
Started | 6 |
Completed | 3 |
Not Completed | 3 |
Reason Not Completed | |
Insufficient clinical response | 3 |
Period Title: Part 2(Week17 to Maximum of 119.6 Weeks) | |
Started | 3 |
Completed | 1 |
Not Completed | 2 |
Reason Not Completed | |
Coil Embolization | 1 |
Change of treatment plan | 1 |
Baseline Characteristics
Arm/Group Title | Sildenafil | |
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Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Weeks 4, 8, and 16 in Part 1 of the study. Participants who completed Part 1 and required continuing treatment with Sildenafil, received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Weeks 28, 40, 52 and thereafter every 12 weeks until Sildenafil obtained marketing approval (up to a maximum of 119.6 weeks). Participants with <= 20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with > 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets. | |
Overall Number of Baseline Participants | 6 | |
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Efficacy analysis set included all participants who received at least 1 dose of study drug.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
<=18 years |
6 100.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 6 participants | |
6.7 (5.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
Female |
3 50.0%
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Male |
3 50.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) |
ClinicalTrials.gov Identifier: | NCT01642407 |
Other Study ID Numbers: |
A1481298 |
First Submitted: | June 15, 2012 |
First Posted: | July 17, 2012 |
Results First Submitted: | November 3, 2016 |
Results First Posted: | April 4, 2017 |
Last Update Posted: | February 1, 2021 |