A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
Public ClinicalTrials.gov record NCT01720524. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT
Study identification
- NCT ID
- NCT01720524
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Industry
- Enrollment
- 59 participants
Conditions and interventions
Interventions
- iv sildenafil Drug
- placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 0 Days to 4 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 4, 2013
- Primary completion
- Oct 16, 2018
- Completion
- Sep 27, 2020
- Last update posted
- Aug 15, 2021
2013 – 2020
United States locations
- U.S. sites
- 20
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| University of California Davis Medical Center | Sacramento | California | 95825 | — |
| Children´s National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | — |
| Sydney and Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | — |
| Children's Mercy Hospitals & Clinics | Kansas City | Missouri | 64108 | — |
| Duke University Medical Center (DUMC) | Durham | North Carolina | 27710 | — |
| Fairview Hospital | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| OU Follow-Up Program, PREMIEr Clinic, Children's Hospital | Oklahoma City | Oklahoma | 73104 | — |
| OU Neonatal Intensive Care Unit at Children's Hospital | Oklahoma City | Oklahoma | 73104 | — |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Henry Zarrow Neonatal Intensive Care Unit, Children's Hospital at Saint Francis | Tulsa | Oklahoma | 74136 | — |
| Warren Cancer Research Foundation | Tulsa | Oklahoma | 74136 | — |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232 | — |
| Seattle Children's Research Institute | Seattle | Washington | 98101 | — |
| Seattle Childrens Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01720524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 15, 2021 · Synced May 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01720524 live on ClinicalTrials.gov.