Comparison · NCT01720524-0ec15449
IV Sildenafil vs Placebo: Number of Participants With Laboratory Abnormalities
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. IV Sildenafil vs Placebo: Number of Participants With Laboratory Abnormalities. Trial comparisons, record NCT01720524-0ec15449. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01720524-0ec15449
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.931 | 0.78 | 0.981 | wilson | |
| Risk in group 2 | 0.786 | 0.605 | 0.898 | wilson | |
| Risk difference, group 1 minus group 2 | 0.145 | -0.0425 | 0.333 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 0.953 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 3.68 | 0.675 | 20.1 | log | |
| Number needed to treat, for one more participant with the outcome on IV Sildenafil than on Placebo | 6.88 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | IV Sildenafil | Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study. | 27 | 29 | OG000 |
| Group 2 | Placebo | Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study. | 22 | 28 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Laboratory Abnormalities
- Description
Criteria for laboratory values: Hematology: hemoglobin, hematocrit, red blood cell count \<0.8\*lower limit of normal (LLN), platelets\<0.5\*LLN, \>1.75\*upper limit of normal (ULN), white blood cells count \<0.6\*LLN, \>1.5\*ULN; Liver function: total and direct bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN, total protein \<0.8\*LLN, \>1.2\*ULN; Renal function: blood urea nitrogen, creatinine \>1.3\*ULN; Electrolytes: sodium \<0.95\*LLN, \>1.05\*ULN, potassium, chloride, calcium, bicarbonate (venous) \<0.9\*LLN, \>1.1\*ULN.
- Time frame
- Up to 14 days from initiation of study drug infusion
- Population
- The safety population included all participants treated with study treatment. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
- NCT number
- NCT01720524
- Phases
- PHASE3
- Conditions
- Pulmonary Hypertension, Familial Persistent, of the Newborn
- Interventions
- placebo, iv sildenafil
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2020-03-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01720524?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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