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NCT01557660 Clinical Trial

Inhaled Treprostinil for PAH: Open-label Extension

Pulmonary Arterial Hypertension Clinical Trial

— INTREPID - OL  

Official title:
Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01557660
Other study ID # RIN-PH-303
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 14, 2012
Last updated March 23, 2012
Start date June 2012
Est. completion date December 2018

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 DevicesIsrael: Ministry of HealthItaly: The Italian Medicines AgencyMexico: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Russia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilTaiwan: Department of HealthUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

Open-label extension of RIN-PH-302.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Participation and completion of all required visits for study RIN-PH-302.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• inhaled treprostinil
0.6mg/mL inhalation solution, up to 12 breaths four times a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
United Therapeutics

Outcome
Type Measure Description Time frame Safety issue
Primary Long term safety of inhaled treprostinil up to 5 years Yes
Secondary Six-minute walk distance up to 5 years No
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