TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-10

Study Completion Date

2014-02-25

Brief Summary

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This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous Treprostinil

Intravenous treprostinil was supplied as 1 mg/mL.

Group Type EXPERIMENTAL

Intravenous Treprostinil

Intervention Type DRUG

Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.

Interventions

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Intravenous Treprostinil

Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.

Intervention Type DRUG

Other Intervention Names

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Remodulin

Eligibility Criteria

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Inclusion Criteria

* Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

Exclusion Criteria

* Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No