Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (INTREPID)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01557647
First received: March 14, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Inhaled treprostinil
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Six-minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to clinical worsening [ Time Frame: 1 day to 2.5 years. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled treprostinil Drug: Inhaled treprostinil
0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.
Placebo Comparator: placebo Drug: Placebo
placebo inhalation solution

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01557647     History of Changes
Other Study ID Numbers: RIN-PH-302
Study First Received: March 14, 2012
Last Updated: March 23, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicinal Products and Health Products
Chile: Instituto de Salud Publica de Chile
China: Food and Drug Administration
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Taiwan: Department of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014