Trial · NCT00467896
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Inhalation-times Rate - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Primary | Inhalation-times Rate - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Primary | Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15) | 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15 | Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Number of Daily Inhalations - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Number of Daily Inhalations - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Daily Inhalation Duration - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Daily Inhalation Duration - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Systolic Blood Pressure - Iloprost PD-6 (Period I) | Day 1, prior to first dose of iloprost PD-15 | SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 |
| Secondary | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | Day 1 and Day 7, following the first dose of iloprost PD-15 | SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 |
| Secondary | Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | Day 1, prior to first dose of iloprost PD-15 | DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 |
| Secondary | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | Day 1 and Day 7, following the first dose of iloprost PD-15 | DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 |
| Secondary | Heart Rate (HR) - Iloprost PD-6 (Period I) | Day 1, prior to first dose of iloprost PD-15 | HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 |
| Secondary | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | Day 1 and Day 7, following the first dose of iloprost PD-15 | HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 |
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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