Trial · NCT00709098

Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

NCT00709098, Phase 3, Completed, Actelion; results first posted 2012-10-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension. Trials, record NCT00709098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00709098

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
NCT number: NCT00709098
Status: Completed
Phases: Phase 3
Enrollment: 49 participants, actual
Lead sponsor: Actelion
Conditions: Pulmonary Arterial Hypertension
Interventions: iloprost, iloprost
First posted: 2008-07-03
Last updated: 2015-09-28
Results first posted: 2012-10-29

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment-emergent Adverse Events	Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.	Number of adverse events
Primary	Treatment-emergent Serious Adverse Events	Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.	Number of serious adverse events
Primary	Adverse Events Leading to Premature Discontinuation of Study Drug	Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.	Number of adverse events leading to discontinuation of study treatment
Primary	Patients With Adverse Events Leading to Premature Discontinuation of Study Drug	Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.	Number of patients with adverse events leading to discontinuation of study treatment
Other	Average Inhalation Time	12 weeks	Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment-emergent Adverse Events	Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.	Safety population	adverse events	NUMBER
PRIMARY	Treatment-emergent Serious Adverse Events	Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.	Safety population	serious adverse events	NUMBER
PRIMARY	Adverse Events Leading to Premature Discontinuation of Study Drug	Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.	Safety population	adverse events	NUMBER
PRIMARY	Patients With Adverse Events Leading to Premature Discontinuation of Study Drug	Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.		participants	NUMBER
OTHER_PRE_SPECIFIED	Average Inhalation Time	12 weeks	All treated population	minutes	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Units
Treatment-emergent Adverse Events	Iloprost Power 6 (Double-blind Period)	148	adverse events
Treatment-emergent Adverse Events	Iloprost Power 15 (Double-blind Period)	139	adverse events
Treatment-emergent Adverse Events	Iloprost Power 15 (Open-label Period)	126	adverse events
Treatment-emergent Serious Adverse Events	Iloprost Power 6 (Double-blind Period)	11	serious adverse events
Treatment-emergent Serious Adverse Events	Iloprost Power 15 (Double-blind Period)	11	serious adverse events
Treatment-emergent Serious Adverse Events	Iloprost Power 15 (Open-label Period)	10	serious adverse events
Adverse Events Leading to Premature Discontinuation of Study Drug	Iloprost Power 6 (Double-blind Period)	3	adverse events
Adverse Events Leading to Premature Discontinuation of Study Drug	Iloprost Power 15 (Double-blind Period)	10	adverse events
Adverse Events Leading to Premature Discontinuation of Study Drug	Iloprost Power 15 (Open-label Period)	7	adverse events
Patients With Adverse Events Leading to Premature Discontinuation of Study Drug	Iloprost Power 6 (Double-blind Period)	2	participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Double-blind Period	STARTED	Iloprost Power 6 (Double-blind Period)	25
Double-blind Period	STARTED	Iloprost Power 15 (Double-blind Period)	24
Double-blind Period	STARTED	Iloprost Power 15 (Open-label Period)	0
Double-blind Period	COMPLETED	Iloprost Power 6 (Double-blind Period)	19
Double-blind Period	COMPLETED	Iloprost Power 15 (Double-blind Period)	16
Double-blind Period	COMPLETED	Iloprost Power 15 (Open-label Period)	0
Double-blind Period	NOT COMPLETED	Iloprost Power 6 (Double-blind Period)	6
Double-blind Period	NOT COMPLETED	Iloprost Power 15 (Double-blind Period)	8
Double-blind Period	NOT COMPLETED	Iloprost Power 15 (Open-label Period)	0
Open-label Period	STARTED	Iloprost Power 6 (Double-blind Period)	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events177

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
other	HEADACHE	Nervous system disorders	Iloprost Power 6 (Double-blind Period)	11	25
other	HEADACHE	Nervous system disorders	Iloprost Power 15 (Double-blind Period)	13	24
other	HEADACHE	Nervous system disorders	Iloprost Power 15 (Open-label Period)	2	32
other	COUGH	Respiratory, thoracic and mediastinal disorders	Iloprost Power 6 (Double-blind Period)	7	25
other	COUGH	Respiratory, thoracic and mediastinal disorders	Iloprost Power 15 (Double-blind Period)	10	24
other	COUGH	Respiratory, thoracic and mediastinal disorders	Iloprost Power 15 (Open-label Period)	2	32
other	DIZZINESS	Nervous system disorders	Iloprost Power 6 (Double-blind Period)	8	25
other	DIZZINESS	Nervous system disorders	Iloprost Power 15 (Double-blind Period)	7	24
other	DIZZINESS	Nervous system disorders	Iloprost Power 15 (Open-label Period)	4	32
other	FLUSHING	Vascular disorders	Iloprost Power 6 (Double-blind Period)	6	25

1 to 10 of 177Source ClinicalTrials.gov

See all 177 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Iloprost Power 6 (Double-blind Period)
Total, all-cause mortality	Iloprost Power 15 (Double-blind Period)
Total, all-cause mortality	Iloprost Power 15 (Open-label Period)
Total, other adverse events	Iloprost Power 6 (Double-blind Period)	23	25
Total, other adverse events	Iloprost Power 15 (Double-blind Period)	23	24
Total, other adverse events	Iloprost Power 15 (Open-label Period)	25	32
Total, serious adverse events	Iloprost Power 6 (Double-blind Period)	6	25
Total, serious adverse events	Iloprost Power 15 (Double-blind Period)	5	24
Total, serious adverse events	Iloprost Power 15 (Open-label Period)	8	32

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.

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/NCT00709098

GET https://conductscience.org/api/trials/v1/NCT00709098/events?page=2

API reference For AI assistants