Trial · NCT00159913
A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.
NCT00159913, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension. Trials, record NCT00159913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00159913
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.
- NCT number
- NCT00159913
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 235 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Pulmonary Arterial Hypertension, Children
- Interventions
- Sildenafil citrate, Sildenafil citrate, Placebo, Sildenafil citrate
- First posted
- 2005-09-12
- Last updated
- 2021-02-18
- Results first posted
- 2009-07-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Baseline, Week 16 | Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = \[(week 16 value minus baseline mean)/mean at baseline\]\*100%. |
| Primary | Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population | Baseline, Week 16 | Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = \[(week 16 value minus baseline mean)/mean at baseline\]\*100%. |
| Secondary | Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Baseline, Week 16 | mPAP, a hemodynamic parameter, was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in Pulmonary Vascular Resistance Index (PVRI) | Baseline, Week 16 | PVRI equals Pulmonary Vascular Resistance (PVR) times Body Surface Area (BSA). Wood unit = 80dyn•s/cm5. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Percent Change From Baseline to Week 16 in: Respiratory Exchange Ratio (RER) | Baseline, Week 16 | RER is the ratio of carbon dioxide produced to oxygen consumed \[VCO2/VO2\]). Percent change is \[(Week 16 value minus Baseline value)/Baseline value\] \* 100% |
| Secondary | Percent Change From Baseline to Week 16 in Time to Maximum Volume of Oxygen Consumed (VO2) | Baseline, Week 16 | Time to maximum VO2 was assessed on the subset of subjects who are developmentally able to perform the exercise test. Percent change is \[(value at Week 16 minus Baseline value)/Baseline value\] \* 100% |
| Secondary | Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) | Baseline, Week 16 | Change calculated as (mean PAP - PCWP)/COpulm in PVR is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in Cardiac Index (CI) | Baseline, Week 16 | CI is observed value at Week 16 minus Baseline value. Calculated as cardiac output in systemic circulation (COsys) / body surface area (BSA). |
| Secondary | Change From Baseline to Week 16 in Right Atrial Pressure (RAP) | Baseline, Week 16 | RAP was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value. |
| Secondary | Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Physical Scale | Baseline, Week 16 | CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects \>= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social \& school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Baseline, Week 16 | ITT population included all subjects randomised and who received at least one dose of study medication. All subjects developmentally able to perform the exercise test. Subjects assumed developmentally able if they had a CPX exercise assessment at any visit during study using a LOCF (end-of-treatment)approach for handling missing data. | percent change | MEAN |
| SECONDARY | Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Baseline, Week 16 | ITT population, using a LOCF (end-of-treatment) approach for handling missing data. | mm Hg | MEAN |
| SECONDARY | Change From Baseline to Week 16 in Pulmonary Vascular Resistance Index (PVRI) | Baseline, Week 16 | ITT population, LOCF | wood units. m2 | MEAN |
| SECONDARY | Percent Change From Baseline to Week 16 in: Respiratory Exchange Ratio (RER) | Baseline, Week 16 | ITT population, LOCF (end-of-treatment) approach for handling missing values. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline to Week 16 in Time to Maximum Volume of Oxygen Consumed (VO2) | Baseline, Week 16 | ITT population, LOCF (end-of-treatment) approach for handling missing values. | percent change | MEAN |
| SECONDARY | Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) | Baseline, Week 16 | ITT population, using LOCF (end of treatment) approach for handling missing data | wood units | MEAN |
| SECONDARY | Change From Baseline to Week 16 in Cardiac Index (CI) | Baseline, Week 16 | ITT population, using LOCF (end of treatment) approach for handling missing data. | liters/minute/meters squared | MEAN |
| SECONDARY | Change From Baseline to Week 16 in Right Atrial Pressure (RAP) | Baseline, Week 16 | ITT population, using LOCF (end of treatment) approach for missing data. | mm Hg | MEAN |
| SECONDARY | Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Physical Scale | Baseline, Week 16 | ITT population, includes subjects \>= 5 years with a valid questionnaire available in the subject's first language. | score on scale | MEAN |
| SECONDARY | Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Psychosocial Scales | Baseline, Week 16 | ITT population, includes subjects \>= 5years with a valid questionnaire available in the subject's first language. | score on scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Sildenafil Low Dose | 6.44 | Standard Deviation 20.16 | percent change | |
| Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Sildenafil Medium Dose | 13.40 | Standard Deviation 19.50 | percent change | |
| Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Sildenafil High Dose | 10.58 | Standard Deviation 15.51 | percent change | |
| Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Combined Sildenafil | 10.24 | Standard Deviation 18.39 | percent change | |
| Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population | Placebo | 0.53 | Standard Deviation 15.91 | percent change | |
| Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Sildenafil Low Dose | 0.9 | Standard Deviation 12.3 | mm Hg | |
| Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Sildenafil Medium Dose | -3.9 | Standard Deviation 12.0 | mm Hg | |
| Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Sildenafil High Dose | -7.4 | Standard Deviation 15.4 | mm Hg | |
| Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Combined Sildenafil | -4.3 | Standard Deviation 13.9 | mm Hg | |
| Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP) | Placebo | -0.4 | Standard Deviation 15.9 | mm Hg |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sildenafil Low Dose | 42 | |
| Overall Study | STARTED | Sildenafil Medium Dose | 55 | |
| Overall Study | STARTED | Sildenafil High Dose | 77 | |
| Overall Study | STARTED | Placebo | 60 | |
| Overall Study | COMPLETED | Sildenafil Low Dose | 40 | |
| Overall Study | COMPLETED | Sildenafil Medium Dose | 55 | |
| Overall Study | COMPLETED | Sildenafil High Dose | 75 | |
| Overall Study | COMPLETED | Placebo | 58 | |
| Overall Study | NOT COMPLETED | Sildenafil Low Dose | 2 | |
| Overall Study | NOT COMPLETED | Sildenafil Medium Dose | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events240
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil Low Dose | 0 | 42 | |
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil Medium Dose | 2 | 55 | |
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil High Dose | 0 | 77 | |
| other | Anaemia | Blood and lymphatic system disorders | Combined Sildenafil | 2 | 174 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 60 | |
| other | Conjunctivitis | Eye disorders | Sildenafil Low Dose | 0 | 42 | |
| other | Conjunctivitis | Eye disorders | Sildenafil Medium Dose | 0 | 55 | |
| other | Conjunctivitis | Eye disorders | Sildenafil High Dose | 2 | 77 | |
| other | Conjunctivitis | Eye disorders | Combined Sildenafil | 2 | 174 | |
| other | Conjunctivitis | Eye disorders | Placebo | 2 | 60 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil Low Dose | ||
| Total, all-cause mortality | Sildenafil Medium Dose | ||
| Total, all-cause mortality | Sildenafil High Dose | ||
| Total, all-cause mortality | Combined Sildenafil | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sildenafil Low Dose | 22 | |
| Total, other adverse events | Sildenafil Medium Dose | 37 | |
| Total, other adverse events | Sildenafil High Dose | 44 | |
| Total, other adverse events | Combined Sildenafil | 102 | |
| Total, other adverse events | Placebo | 29 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00159913
GET https://conductscience.org/api/trials/v1/NCT00159913/results?page=2