Trial · NCT00723554
Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
NCT00723554, Phase 3, Terminated, Actelion; results first posted 2013-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iloprost Power Disc-15 in Pulmonary Arterial Hypertension. Trials, record NCT00723554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723554
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
- NCT number
- NCT00723554
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 63 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Iloprost PD-6, Iloprost PD-15
- First posted
- 2008-07-28
- Last updated
- 2013-04-04
- Results first posted
- 2013-02-15
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Reporting Treatment-emergent Adverse Events (AEs) | From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours | Number of patients reporting at least one treatment-emergent AE/Serious AE |
| Primary | Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE | From the first dose of investigational product to study discontinuation, an average of approximately 268 days | Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment |
| Primary | Number of Patients Reporting Treatment-emergent Serious AEs | From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours | Number of patients reporting at least one treatment-emergent serious AEs |
| Primary | Systolic Blood Pressure - Iloprost PD-6 (Period 1) | Day 1 | Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15 |
| Primary | Systolic Blood Pressure - Iloprost PD-15 (Period 2) | Day 28 | Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15 |
| Primary | Systolic Blood Pressure - Iloprost PD-15 (Period 3) | an average of approximately 268 days | Systolic blood pressure was measured at the end of study visit |
| Primary | Change in Systolic Blood Pressure - (Period 1 to Period 2) | Day 1 and Day 28 | Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2) |
| Primary | Change in Systolic Blood Pressure - (Period 1 to Period 3) | Day 1 and End of study visit, an average of approximately 268 days | Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3) |
| Primary | Diastolic Blood Pressure - Iloprost PD-6 (Period 1) | Day 1 | Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15 |
| Primary | Diastolic Blood Pressure - Iloprost PD-15 (Period 2) | Day 28 | Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Reporting Treatment-emergent Adverse Events (AEs) | From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours | Safety population | participants | NUMBER |
| PRIMARY | Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE | From the first dose of investigational product to study discontinuation, an average of approximately 268 days | Safety population | participants | NUMBER |
| PRIMARY | Number of Patients Reporting Treatment-emergent Serious AEs | From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours | Safety population | participants | NUMBER |
| PRIMARY | Systolic Blood Pressure - Iloprost PD-6 (Period 1) | Day 1 | Safety population | mmHg | MEAN |
| PRIMARY | Systolic Blood Pressure - Iloprost PD-15 (Period 2) | Day 28 | Safety population - missing data were not imputed | mmHg | MEAN |
| PRIMARY | Systolic Blood Pressure - Iloprost PD-15 (Period 3) | an average of approximately 268 days | Safety population - missing data were not imputed | mmHg | MEAN |
| PRIMARY | Change in Systolic Blood Pressure - (Period 1 to Period 2) | Day 1 and Day 28 | Safety population - missing data were not imputed | mmHg | MEAN |
| PRIMARY | Change in Systolic Blood Pressure - (Period 1 to Period 3) | Day 1 and End of study visit, an average of approximately 268 days | Safety population - missing data were not imputed | mmHg | MEAN |
| PRIMARY | Diastolic Blood Pressure - Iloprost PD-6 (Period 1) | Day 1 | mmHg | MEAN | |
| PRIMARY | Diastolic Blood Pressure - Iloprost PD-15 (Period 2) | Day 28 | Safety population - missing data were not imputed | mmHg | MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group79
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Reporting Treatment-emergent Adverse Events (AEs) | Iloprost | 53 | participants | ||
| Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE | Iloprost | 8 | participants | ||
| Number of Patients Reporting Treatment-emergent Serious AEs | Iloprost | 18 | participants | ||
| Systolic Blood Pressure - Iloprost PD-6 (Period 1) | Iloprost | 117.7 | Standard Deviation 15.61 | mmHg | |
| Systolic Blood Pressure - Iloprost PD-15 (Period 2) | Iloprost | 116.2 | Standard Deviation 14.71 | mmHg | |
| Systolic Blood Pressure - Iloprost PD-15 (Period 3) | Iloprost | 119.0 | Standard Deviation 17.47 | mmHg | |
| Change in Systolic Blood Pressure - (Period 1 to Period 2) | Iloprost | -1.9 | Standard Deviation 13.07 | mmHg | |
| Change in Systolic Blood Pressure - (Period 1 to Period 3) | Iloprost | 0.8 | Standard Deviation 17.82 | mmHg | |
| Diastolic Blood Pressure - Iloprost PD-6 (Period 1) | Iloprost | 67.6 | Standard Deviation 10.57 | mmHg | |
| Diastolic Blood Pressure - Iloprost PD-15 (Period 2) | Iloprost | 67.0 | Standard Deviation 8.86 | mmHg |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Iloprost | 63 | |
| Overall Study | COMPLETED | Iloprost | 34 | |
| Overall Study | NOT COMPLETED | Iloprost | 29 |
Source ClinicalTrials.gov
Adverse events63
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 | Iloprost | 4 | 63 | |
| other | PALPITATIONS | Cardiac disorders | Iloprost | 5 | 63 | |
| other | VERTIGO | Ear and labyrinth disorders | Iloprost | 3 | 63 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Iloprost | 4 | 63 | |
| other | DIARRHOEA | Gastrointestinal disorders | Iloprost | 9 | 63 | |
| other | NAUSEA | Gastrointestinal disorders | Iloprost | 9 | 63 | |
| other | CHEST PAIN | General disorders | Iloprost | 4 | 63 | |
| other | FATIGUE | General disorders | Iloprost | 10 | 63 | |
| other | OEDEMA | General disorders | Iloprost | 4 | 63 | |
| other | ACUTE SINUSITIS | Infections and infestations | Iloprost | 3 | 63 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iloprost | ||
| Total, other adverse events | Iloprost | 50 | 63 |
| Total, serious adverse events | Iloprost | 18 | 63 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00723554
GET https://conductscience.org/api/trials/v1/NCT00723554/registered?page=2