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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

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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

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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.

ListOutcomeTime frameDescription
Primary6-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.
SecondaryBorg Dyspnea ScoreStudy 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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY6-minute-walk Distance (6MWD)Study day 2 or study day 3The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.metersLEAST_SQUARES_MEAN
SECONDARYBorg Dyspnea ScoreStudy day 2 or study day 3The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.scores on a scaleMEAN

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
6-minute-walk Distance (6MWD)6MWD After Placebo Treatment330.095% Confidence Interval 22.84meters
6-minute-walk Distance (6MWD)6MWD After Iloprost (5 µg) Treatment328.695% Confidence Interval 55.28meters
Borg Dyspnea ScoreBorg Dyspnea Score After Placebo Treatment3.5Standard Deviation 2.23scores on a scale
Borg Dyspnea ScoreBorg Dyspnea Score After Iloprost (5 µg) Treatment3.4Standard Deviation 2.25scores on a scale

Participant flow8

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIloprost (5µg) / Placebo33
Overall StudySTARTEDPlacebo / Iloprost (5 µg)37
Overall StudyDouble-blind Crossover-periodIloprost (5µg) / Placebo31
Overall StudyDouble-blind Crossover-periodPlacebo / Iloprost (5 µg)33
Overall StudyCOMPLETEDIloprost (5µg) / Placebo30
Overall StudyCOMPLETEDPlacebo / Iloprost (5 µg)33
Overall StudyNOT COMPLETEDIloprost (5µg) / Placebo3
Overall StudyNOT COMPLETEDPlacebo / Iloprost (5 µg)4

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherCoughRespiratory, thoracic and mediastinal disordersIloprost (5µg) / Placebo431
otherCoughRespiratory, thoracic and mediastinal disordersPlacebo / Iloprost (5 µg)433
otherDiarrhoeaGastrointestinal disordersIloprost (5µg) / Placebo031
otherDiarrhoeaGastrointestinal disordersPlacebo / Iloprost (5 µg)233
otherDizzinessNervous system disordersIloprost (5µg) / Placebo231
otherDizzinessNervous system disordersPlacebo / Iloprost (5 µg)433
otherDysphoniaRespiratory, thoracic and mediastinal disordersIloprost (5µg) / Placebo231
otherDysphoniaRespiratory, thoracic and mediastinal disordersPlacebo / Iloprost (5 µg)033
otherDyspnoeaRespiratory, thoracic and mediastinal disordersIloprost (5µg) / Placebo131
otherDyspnoeaRespiratory, thoracic and mediastinal disordersPlacebo / Iloprost (5 µg)333

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIloprost (5µg) / Placebo
Total, all-cause mortalityPlacebo / Iloprost (5 µg)
Total, other adverse eventsIloprost (5µg) / Placebo1631
Total, other adverse eventsPlacebo / Iloprost (5 µg)2033
Total, serious adverse eventsIloprost (5µg) / Placebo031
Total, serious adverse eventsPlacebo / Iloprost (5 µg)133

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

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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