Epoprostenol for Injection in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01105091
• Date of registration: 15/04/2010
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Epoprostenol for Injection in Pulmonary Arterial Hypertension EPITOME-1
• Scientific 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-naïve Patients With Pulmonary Arterial Hypertension (PAH)
• Date of first enrolment: March 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01105091
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Wade Benton, PharmD
• Affiliation: Actelion

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Flolan®

Drug: ACT-385781A (Actelion Epoprostenol)

Primary Outcome(s)

Six-minute Walk Distance (6MWD) - Baseline and Day 28 [Time Frame: Baseline and 28 days (+3 days)]

Blood Pressure - Baseline and Day 28 [Time Frame: Baseline and 28 days]

Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min [Time Frame: Day 1]

Body Weight - Baseline and Day 28 [Time Frame: Baseline and 28 days]

Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min [Time Frame: Day 1]

Heart Rate - Baseline and Day 28 [Time Frame: Baseline and 28 days]

Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28 [Time Frame: Baseline and 28 days]

Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min [Time Frame: Day 1]

Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min [Time Frame: Day 1]

Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28 [Time Frame: From baseline to 28 days (+3 days)]

Secondary ID(s)

AC-066A401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01105091