Trial · NCT00709956
Iloprost Power 15 in Pulmonary Arterial Hypertension
NCT00709956, Phase 3, Completed, Actelion; results first posted 2012-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iloprost Power 15 in Pulmonary Arterial Hypertension. Trials, record NCT00709956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00709956
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iloprost Power 15 in Pulmonary Arterial Hypertension
- NCT number
- NCT00709956
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 64 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- iloprost (5 µg), placebo
- First posted
- 2008-07-03
- Last updated
- 2025-02-04
- Results first posted
- 2012-10-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-minute-walk Distance (6MWD) | Study day 2 or study day 3 | The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk. It was conducted by a trained member of the site staff who was listed on the site's delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization. |
| Secondary | Borg Dyspnea Score | Study day 2 or study day 3 | The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled "extremely severe," or "the worst possible dyspnea imaginable." Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6-minute-walk Distance (6MWD) | Study day 2 or study day 3 | The analysis was per protocol, 64 patients started double blind phase of study, 63 completed. | meters | LEAST_SQUARES_MEAN |
| SECONDARY | Borg Dyspnea Score | Study day 2 or study day 3 | The analysis was per protocol, 64 patients started double blind phase of study, 63 completed. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-minute-walk Distance (6MWD) | 6MWD After Placebo Treatment | 330.0 | 95% Confidence Interval 22.84 | meters | |
| 6-minute-walk Distance (6MWD) | 6MWD After Iloprost (5 µg) Treatment | 328.6 | 95% Confidence Interval 55.28 | meters | |
| Borg Dyspnea Score | Borg Dyspnea Score After Placebo Treatment | 3.5 | Standard Deviation 2.23 | scores on a scale | |
| Borg Dyspnea Score | Borg Dyspnea Score After Iloprost (5 µg) Treatment | 3.4 | Standard Deviation 2.25 | scores on a scale |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Iloprost (5µg) / Placebo | 33 | |
| Overall Study | STARTED | Placebo / Iloprost (5 µg) | 37 | |
| Overall Study | Double-blind Crossover-period | Iloprost (5µg) / Placebo | 31 | |
| Overall Study | Double-blind Crossover-period | Placebo / Iloprost (5 µg) | 33 | |
| Overall Study | COMPLETED | Iloprost (5µg) / Placebo | 30 | |
| Overall Study | COMPLETED | Placebo / Iloprost (5 µg) | 33 | |
| Overall Study | NOT COMPLETED | Iloprost (5µg) / Placebo | 3 | |
| Overall Study | NOT COMPLETED | Placebo / Iloprost (5 µg) | 4 |
Source ClinicalTrials.gov
Adverse events34
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 | Cough | Respiratory, thoracic and mediastinal disorders | Iloprost (5µg) / Placebo | 4 | 31 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo / Iloprost (5 µg) | 4 | 33 | |
| other | Diarrhoea | Gastrointestinal disorders | Iloprost (5µg) / Placebo | 0 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo / Iloprost (5 µg) | 2 | 33 | |
| other | Dizziness | Nervous system disorders | Iloprost (5µg) / Placebo | 2 | 31 | |
| other | Dizziness | Nervous system disorders | Placebo / Iloprost (5 µg) | 4 | 33 | |
| other | Dysphonia | Respiratory, thoracic and mediastinal disorders | Iloprost (5µg) / Placebo | 2 | 31 | |
| other | Dysphonia | Respiratory, thoracic and mediastinal disorders | Placebo / Iloprost (5 µg) | 0 | 33 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Iloprost (5µg) / Placebo | 1 | 31 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo / Iloprost (5 µg) | 3 | 33 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iloprost (5µg) / Placebo | ||
| Total, all-cause mortality | Placebo / Iloprost (5 µg) | ||
| Total, other adverse events | Iloprost (5µg) / Placebo | 16 | 31 |
| Total, other adverse events | Placebo / Iloprost (5 µg) | 20 | 33 |
| Total, serious adverse events | Iloprost (5µg) / Placebo | 0 | 31 |
| Total, serious adverse events | Placebo / Iloprost (5 µg) | 1 | 33 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Iloprost (5µg) / Placebo vs Placebo / Iloprost (5 µg): serious adverse events |
Source Trial comparisons
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/NCT00709956
GET https://conductscience.org/api/trials/v1/NCT00709956/events?page=2