NCT01557660

Brief Summary

Open-label extension of RIN-PH-302.

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

Longer than P75 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withdrawn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
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

6.5 years

First QC Date

March 14, 2012

Last Update Submit

March 23, 2012

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Long term safety of inhaled treprostinil

    up to 5 years

Secondary Outcomes (1)

  • Six-minute walk distance

    up to 5 years

Study Arms (1)

inhaled treprostinil

EXPERIMENTAL
Drug: inhaled treprostinil

Interventions

inhaled treprostinilDRUG

0.6mg/mL inhalation solution, up to 12 breaths four times a day

inhaled treprostinil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Participation and completion of all required visits for study RIN-PH-302.

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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, 2018

Study Completion

December 1, 2018

Last Updated

March 26, 2012

Record last verified: 2012-03