Trial · NCT02060487
Effects of Oral Sildenafil on Mortality in Adults With PAH
NCT02060487, Phase 4, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2022-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Oral Sildenafil on Mortality in Adults With PAH. Trials, record NCT02060487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02060487
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Oral Sildenafil on Mortality in Adults With PAH
- NCT number
- NCT02060487
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 385 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- sildenafil citrate, sildenafil citrate, sildenafil citrate
- First posted
- 2014-02-12
- Last updated
- 2022-05-13
- Other registries' IDs
- eudract:2013-004362-34
- Results first posted
- 2022-05-10
- Limitations and caveats
Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met. For OS and clinical worsening(CW) endpoints, significance level was adjusted to allow for interim analysis. Hence 99.7% CIs were presented instead of 95% CIs. 80mg vs 5mg comparison for OS was primary and it was key secondary for CW. CIs for other dose comparisons for these endpoints were nominal. P-values and CIs for other endpoints were nominal
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Day 1 of study treatment up to date of death (within a maximum duration of 2102 days) | In this outcome measure number of deaths during the study were reported. |
| Secondary | Number of Participants With Clinical Worsening Events | Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days) | Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure \[RHF\], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment. |
| Secondary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6 | Baseline, Month 6 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH. |
| Secondary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12 | Baseline, Month 12 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Day 1 of study treatment up to date of death (within a maximum duration of 2102 days) | The intent-to-treat population (ITT) included all randomized participants treated with study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Worsening Events | Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days) | ITT population included all randomized participants treated with study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6 | Baseline, Month 6 | ITT population included all randomized participants treated with study treatment. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Meters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12 | Baseline, Month 12 | ITT population included all randomized participants treated with study treatment. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Meters | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Sildenafil 5 mg | 34 | Participants | ||
| Overall Survival | Sildenafil 20 mg | 25 | Participants | ||
| Overall Survival | Sildenafil 80 mg | 19 | Participants | ||
| Number of Participants With Clinical Worsening Events | Sildenafil 5 mg | 52 | Participants | ||
| Number of Participants With Clinical Worsening Events | Sildenafil 20 mg | 36 | Participants | ||
| Number of Participants With Clinical Worsening Events | Sildenafil 80 mg | 28 | Participants | ||
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6 | Sildenafil 5 mg | 12.2 | 95% Confidence Interval -0.67 to 25.16 | Meters | |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6 | Sildenafil 20 mg | 27.3 | 95% Confidence Interval 14.52 to 39.99 | Meters | |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6 | Sildenafil 80 mg | 31.2 | 95% Confidence Interval 18.68 to 43.66 | Meters | |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12 | Sildenafil 5 mg | 14.3 | 95% Confidence Interval -0.58 to 29.27 | Meters |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sildenafil 5 mg | 129 | |
| Overall Study | STARTED | Sildenafil 20 mg | 128 | |
| Overall Study | STARTED | Sildenafil 80 mg | 128 | |
| Overall Study | COMPLETED | Sildenafil 5 mg | 0 | |
| Overall Study | COMPLETED | Sildenafil 20 mg | 0 | |
| Overall Study | COMPLETED | Sildenafil 80 mg | 0 | |
| Overall Study | NOT COMPLETED | Sildenafil 5 mg | 129 | |
| Overall Study | NOT COMPLETED | Sildenafil 20 mg | 128 | |
| Overall Study | NOT COMPLETED | Sildenafil 80 mg | 128 |
Source ClinicalTrials.gov
Adverse events2,451
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 5 mg | 5 | 129 | |
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil 20 mg | 3 | 128 | |
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil 80 mg | 11 | 128 | |
| other | Bicytopenia | Blood and lymphatic system disorders | Sildenafil 5 mg | 1 | 129 | |
| other | Bicytopenia | Blood and lymphatic system disorders | Sildenafil 20 mg | 0 | 128 | |
| other | Bicytopenia | Blood and lymphatic system disorders | Sildenafil 80 mg | 0 | 128 | |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Sildenafil 5 mg | 0 | 129 | |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Sildenafil 20 mg | 1 | 128 | |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Sildenafil 80 mg | 0 | 128 | |
| other | Cytopenia | Blood and lymphatic system disorders | Sildenafil 5 mg | 0 | 129 |
1 to 10 of 2,451Source ClinicalTrials.gov
See all 2,451 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil 5 mg | 34 | 129 |
| Total, all-cause mortality | Sildenafil 20 mg | 25 | 128 |
| Total, all-cause mortality | Sildenafil 80 mg | 19 | 128 |
| Total, other adverse events | Sildenafil 5 mg | 108 | 129 |
| Total, other adverse events | Sildenafil 20 mg | 107 | 128 |
| Total, other adverse events | Sildenafil 80 mg | 111 | 128 |
| Total, serious adverse events | Sildenafil 5 mg | 66 | 129 |
| Total, serious adverse events | Sildenafil 20 mg | 49 | 128 |
| Total, serious adverse events | Sildenafil 80 mg | 51 | 128 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38752352 | DERIVED |
Source PubMed
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/NCT02060487
GET https://conductscience.org/api/trials/v1/NCT02060487/events?page=2