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Trial · NCT00723554

Outcomes44

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber 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 hoursSafety populationparticipantsNUMBER
PRIMARYNumber of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AEFrom the first dose of investigational product to study discontinuation, an average of approximately 268 daysSafety populationparticipantsNUMBER
PRIMARYNumber of Patients Reporting Treatment-emergent Serious AEsFrom the first to last dose of investigational product, an average of approximately 268 days, plus 48 hoursSafety populationparticipantsNUMBER
PRIMARYSystolic Blood Pressure - Iloprost PD-6 (Period 1)Day 1Safety populationmmHgMEAN
PRIMARYSystolic Blood Pressure - Iloprost PD-15 (Period 2)Day 28Safety population - missing data were not imputedmmHgMEAN
PRIMARYSystolic Blood Pressure - Iloprost PD-15 (Period 3)an average of approximately 268 daysSafety population - missing data were not imputedmmHgMEAN
PRIMARYChange in Systolic Blood Pressure - (Period 1 to Period 2)Day 1 and Day 28Safety population - missing data were not imputedmmHgMEAN
PRIMARYChange in Systolic Blood Pressure - (Period 1 to Period 3)Day 1 and End of study visit, an average of approximately 268 daysSafety population - missing data were not imputedmmHgMEAN
PRIMARYDiastolic Blood Pressure - Iloprost PD-6 (Period 1)Day 1mmHgMEAN
PRIMARYDiastolic Blood Pressure - Iloprost PD-15 (Period 2)Day 28Safety population - missing data were not imputedmmHgMEAN
PRIMARYDiastolic Blood Pressure - Iloprost PD-15 (Period 3)an average of approximately 268 daysSafety population - missing data were not imputedmmHgMEAN
PRIMARYChange in Diastolic Blood Pressure - (Period 1 to Period 2)Day 1 and Day 28Safety population - missing data were not imputedmmHgMEAN
PRIMARYChange in Diastolic Blood Pressure - (Period 1 to Period 3)Day 1 and End of study visit, an average of approximately 268 daysSafety population - missing data were not imputedmmHgMEAN
PRIMARYHeart Rate - Iloprost PD-6 (Period 1)Day 1Safety populationbeats per minuteMEAN
PRIMARYHeart Rate - Iloprost PD-15 (Period 2)Day 28Safety population - missing data were not imputedbeats per minuteMEAN
PRIMARYHeart Rate - Iloprost PD-15 (Period 3)an average of approximately 268 daysSafety population - missing data were not imputedbeats per minuteMEAN
PRIMARYChange in Heart Rate - (Period 1 to Period 2)Day 1 and Day 28Safety population - missing data were not imputedbeats per minuteMEAN
PRIMARYChange in Heart Rate - (Period 1 to Period 3)Day 1 and End of study visit, an average of approximately 268 daysSafety population - missing data were not imputedbeats per minuteMEAN
SECONDARYAverage Inhalation Time - Iloprost PD-6 (Period 1)average of approximately 28 days
Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.
minutesMEAN
SECONDARYAverage Inhalation Time - Iloprost PD-15 (Period 2)average of approximately 28 days
Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.
minutesMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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