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NCT00467896
A Comparison of Safety and Inhalation Times of Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
Phase 2 trial testing Iloprost PD-6 in Pulmonary Hypertension in 62 participants. Terminated before completion.
1 November 2010
Quick facts
| Lead sponsor | Actelion |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 1 September 2006 |
| Primary completion | 1 November 2010 |
| Estimated completion | 1 June 2011 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Iloprost PD-6 — full drug profile →
- Iloprost PD-15 — full drug profile →
Conditions studied
- Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
Sponsor
Actelion — full company profile →
Who can join
Adults 18 to 85, any sex, with Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Inhalation-times Rate - Iloprost PD-6 (Period I)
Time frame: 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) -
Inhalation-times Rate - Iloprost PD-15 (Period II)
Time frame: 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) -
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
Time frame: 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)
Sponsor's own description
A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00467896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Actelion trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00467896 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Actelion
- Last refreshed: 27 March 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00467896.
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