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NCT01557647 Clinical Trial

Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

Pulmonary Arterial Hypertension Clinical Trial

— INTREPID  

Official title:
Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01557647
Other study ID # RIN-PH-302
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 14, 2012
Last updated March 23, 2012
Start date June 2012
Est. completion date June 2016

Study information
Verified date March 2012
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Ministry for Health and WomenBelgium: Federal Agency for Medicinal Products and Health ProductsChile: Instituto de Salud Pública de ChileChina: Food and Drug AdministrationFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyMexico: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Russia: Ministry of Health of the Russian FederationTaiwan: Department of HealthUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Eligible subjects must:

- Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed),

- Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use.

- Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening.

- Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Inhaled treprostinil
0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.
• Placebo
placebo inhalation solution

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
United Therapeutics

Outcome
Type Measure Description Time frame Safety issue
Primary Six-minute walk test 6 months No
Secondary Time to clinical worsening 1 day to 2.5 years. No
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