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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | 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"
Study Type: | Observational |
Study Design: | Case-Only, Retrospective |
Official Title: | 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" |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients satisfying the eligibility criteria, have at least 32 consecutive days of inhalation times data during period one (baseline), and have at least 6 consecutive days of inhalation time data after beginning period two (active), will be included in the analysis for evaluating improvements in inhalation times associated with use of PD-15. Patients who have a change (dosing change,new medication or elimination of a medication) in their PAH medications during period two, will have their data truncated at the time of the first change in medication. Patients who do not follow the prescribing and patient information labeling for Ventavis during period two will be excluded.
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandy Petersen, MS | 650-243-2359 | sandy.petersen@actelion.com |
Contact: Kathleen Feldkircher | 650-243-2345 | kathleen.feldkircher@actelion.com |
United States, Arizona | |
Pulmonary Associates | Recruiting |
Phoenix, Arizona, United States, 85006 | |
Contact: Liyi Fu, MD 602-258-4951 palyf@aol.com | |
Principal Investigator: David Baratz, MD | |
United States, Louisiana | |
Louisiana State University Health Sciences Center | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Paula Lauto, RN, BSN 504-568-3451 plauto@lsuhsc.edu | |
Principal Investigator: Ben DeBoisblanc, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Allison Thompson, BS 412-647-2820 thompsonac2@upmc.edu | |
Contact: Kirsten Schwoegl 412-647-5363 schwoeglk@upmc.edu | |
Principal Investigator: Michael A Mathier, MD | |
United States, Texas | |
Diagnositc Research Group | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Kathy Canty, RN, BSN 210-692-7157 kcanty@drxg.com | |
Principal Investigator: Charles J Burch, MD | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Royanne Holy 713-798-2684 rholy@bcm.edu | |
Principal Investigator: Adaani Frost, MD | |
United States, Wisconsin | |
Heart Care Associates | Recruiting |
Milwaukee, Wisconsin, United States, 53215 | |
Contact: Don Lobacz 414-649-3438 dlobacz@hrtcare.com | |
Principal Investigator: Ramagopal Tumuluri, MD |
Principal Investigator: | Michael A Mathier, MD | University of Pittsburgh |
Principal Investigator: | Ramagopal Tumuluri, MD | Heart Care Associates, LLC |
Principal Investigator: | Charles J. Burch, MD | Diagnostics Research Group |
Principal Investigator: | David Baratz, MD | Pulmonary Associates |
Principal Investigator: | Ben DeBoisblanc, MD | Louisiana State University Health Sciences Center |
Principal Investigator: | Adaani Frost, MD | Baylor College of Medicine |
Responsible Party: | Actelion Pharmaceuticals, US, Inc. ( Actelion ) |
Study ID Numbers: | C200-008 |
Study First Received: | April 27, 2007 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00467896 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PAH iloprost Ventavis |
Pulmonary Arterial Hypertension Actelion Pharmaceuticals Cotherix |
Iloprost Vasodilator Agents Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Idiopathic Pulmonary Hypertension Vascular Diseases Platelet Aggregation Inhibitors Cardiovascular Agents Hypertension |
Vasodilator Agents Hematologic Agents Vascular Diseases Cardiovascular Agents Pharmacologic Actions Iloprost Respiratory Tract Diseases |
Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Hypertension |