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NCT03492177 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
A Phase 2 study of Pulmonary Arterial Hypertension, sponsored by Actelion.
- Active
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT03492177: Active Phase 2 study of Pulmonary Arterial Hypertension, sponsored by Actelion.
NCT03492177 is a Phase 2 study of Pulmonary Arterial Hypertension that is active but no longer recruiting, run by Actelion. The registered enrollment target is 63 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03492177, a Phase 2 study of Pulmonary Arterial Hypertension, is active but no longer recruiting, sponsored by Actelion.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (\>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.
Primary Outcome
AUCτ, ss, combined was defined as the area under the plasma concentration-time curve over one dosing interval at steady state. AUCτ,ss,combined was calculated as 1/38 AUCτ,ss,selexipag plus 37/38 AUCτ,ss,ACT-333679.
Conditions Studied
Interventions
- DRUG selexipag (Uptravi)
Study Locations (20)
Other
- State Institution Republican Scientific And Practical Center For Pediatric Surgery - Minsk
- Health Institution 4Th City Children'S Clinical Hospital - Minsk
- UZ Gent - Ghent
- Beijing Anzhen Hospital - Beijing
- Shanghai Childrens Medical Center - Shanghai
- CHU Arnaud de Villeneuve - Montpellier
- Hôpital Necker - Enfants Malades - Paris
- Chu Hopital Des Enfants - Toulouse
- Universitätsklinikum Freiburg Zentrum - Freiburg im Breisgau
- Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály - Budapest
- Schneider Children's Medical Center - Petach Tikvah
- Sheba Medical Center - Ramat Gan
- Sarawak Heart Center - Kota Samarahan
- Institut Jantung Negara (National Heart Institute) - Kuala Lumpur
- Wojewodzki Szpital Specjalistyczny We Wroclawiu - Wroclaw
- Kazan State Medical University - Kazan'
Colorado
- Children'S Hospital Cardiac Care Center University Of Colorado - Aurora
Iowa
- University of Iowa Hospital - Iowa City
Washington
- Seattle Children's Hospital - Seattle
Quebec
- Centre Hospitalier Sainte Justine - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03492177 still lists
NCT03492177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which selexipag (Uptravi) is the first listed.
NCT03492177 names 20 study sites across 5 states, led by Other, Colorado, Iowa.
Frequently Asked Questions
What is clinical trial NCT03492177 about?
NCT03492177 is a clinical study titled "A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension". The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (\>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertensio...
What is the current status of trial NCT03492177?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2018-07-23. Estimated completion is 2026-12-31.
What conditions does trial NCT03492177 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT03492177?
The interventions under investigation include: selexipag (Uptravi) (DRUG).
Who is sponsoring clinical trial NCT03492177?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03492177 being conducted?
This trial has 20 study locations across Colorado, Iowa, Washington, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03492177's enrollment target sits among peer trials
63 27th of 63 higher than 36 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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