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NCT00159913 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
NCT00159913 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 235 participants.
The verdict
NCT00159913, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
Study Summary
This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.
Interventions
- DRUG Placebo
- DRUG Sildenafil citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2003-08 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00159913
The ClinicalTrials.gov registry entry for NCT00159913 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00159913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00159913 about?
NCT00159913 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.". This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in thre...
What is the current status of trial NCT00159913?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2003-08. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00159913?
The interventions under investigation include: Placebo (DRUG), Sildenafil citrate (DRUG).
Who is sponsoring clinical trial NCT00159913?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
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