NCT01557647

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Typical duration for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

3.5 years

First QC Date

March 14, 2012

Last Update Submit

March 23, 2012

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Six-minute walk test

    6 months

Secondary Outcomes (1)

  • Time to clinical worsening

    1 day to 2.5 years.

Study Arms (2)

inhaled treprostinil

EXPERIMENTAL
Drug: Inhaled treprostinil

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Inhaled treprostinilDRUG

0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.

inhaled treprostinil
PlaceboDRUG

placebo inhalation solution

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 19, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

March 26, 2012

Record last verified: 2012-03