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Epoprostenol for Injection in Pulmonary Arterial Hypertension

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: ACT-385781A (Actelion Epoprostenol) (Drug); Flolan® (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Wade Benton, PharmD, Study Director, Affiliation: Actelion

Summary

This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are na´ve to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from 8 U. S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2: 1 respectively) for 28 days of treatment.

Clinical Details

Official title: A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan« in Injectable Prostanoid Treatment-na´ve Patients With Pulmonary Arterial Hypertension (PAH)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min

Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min

Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min

Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min

Six-minute Walk Distance (6MWD) - Baseline and Day 28

Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28

Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28

Blood Pressure - Baseline and Day 28

Heart Rate - Baseline and Day 28

Body Weight - Baseline and Day 28

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female subjects aged 18-65 years 2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I:

- Idiopathic (IPAH)

- Heritable (HPAH)

- Associated (APAH) with

- Connective tissue diseases

- Drugs and toxins

3. Patients with PAH in modified NYHA functional class III or IV at the time of enrollment in need of injectable epoprostenol. 4. Patients must be injectable prostanoid treatment-naïve and either

- newly diagnosed and not yet treated with specific PAH therapies or

- currently treated with existing background PAH therapy with one or more of the

following medications for 90 days prior to enrollment and on a stable dose for 30 days prior to enrollment:

- Bosentan

- Ambrisentan

- Sildenafil

- Tadalafil

5. Women of childbearing potential must use a reliable method of contraception. Exclusion Criteria: 1. Patients with respiratory and/or cardiovascular distress in need of emergency care including i. v. epoprostenol administration or any vasopressive i. v. drugs 2. Known pulmonary veno-occlusive disease (PVOD) 3. Current use of i. v. inotropic agents 4. Tachycardia with heart rate > 120 beats/min 5. Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria 6. Known hypersensitivity to the formulations of ACT-385781A or any of its excipients, and Flolan or any of its excipients 7. Use of inhaled iloprost or treprostinil during the week prior to screening 8. Cerebrovascular events (e. g., transient ischemic attack or stroke) within 6 months of screening 9. History of myocardial infarction 10. History of left-sided heart disease, including any of the following:

- hemodynamically significant aortic or mitral valve disease

- restrictive or congestive cardiomyopathy

- left ventricular ejection fraction < 40% by multigated radionucleotide

angiogram(MUGA),angiography, or echocardiography

- unstable angina pectoris

- life-threatening cardiac arrhythmias

11. Chronic bleeding disorder 12. Infection(s) within the past month that in the mind of the investigator would contraindicate the use of epoprostenol 13. Pregnancy or breast-feeding 14. Participation in another clinical trial, except observational (noninterventional), or receipt of an investigational product within 30 days prior to randomization 15. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease 16. Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months

Locations and Contacts

University of California - San Diego, La Jolla, California 92037, United States

University of Colorado - Denver, Aurora, Colorado 80045, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Vanderbilt Medical Center, Nashville, Tennessee 37232, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Additional Information

Starting date: March 2010
Last updated: November 29, 2012

Page last updated: August 23, 2015

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