Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (INTREPID)
This study has been withdrawn prior to enrollment.
Sponsor:
United Therapeutics
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
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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:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
U.S. FDA Resources
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 May 21, 2013