Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension (TRUST-1)
Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV) infection or collagen vascular disease).
Pulmonary Arterial Hypertension
Drug: Remodulin (treprostinil sodium)
|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:||Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension|
- Six-minute walk distance [ Time Frame: Twelve Weeks ] [ Designated as safety issue: No ]Placebo-corrected change in 6-minute walk distance from Baseline to Week 12.
- Borg Dyspnea Score [ Time Frame: Twelve Weeks ] [ Designated as safety issue: Yes ]The Bord dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).
- Dyspnea-Fatigue Index [ Time Frame: Twelve weeks ] [ Designated as safety issue: Yes ]The dyspnea-fatigue index was assessed at Baseline, Weeks 1, 4, 8 ans 12. Each of the three components of the dyspnea-fatigue index were rated on a scale of 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.
- NYHA Functional Class [ Time Frame: Twelve Weeks ] [ Designated as safety issue: Yes ]Changes from Baseline in NYHA Functional Class will be summarized and compared between treatment groups at Weeks 1, 4, 8 and 12.
- Clinical Worsening [ Time Frame: Twelve Weeks ] [ Designated as safety issue: Yes ]Clinical worsening was defined as worsening PAH resulting in death, transplant, hospitalization, necessity to unblind for rescue therapy, or an inability to physically perform the walk assessment. Incidence of clinical worsening and the time from Baseline to clinical worsening will be compared between treatment groups.
- Combined Walk and Borg Dyspnea Score [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]The intent of the Six-Minute Walk Test is to determine how much patients can do during the course of carrying out activities of daily living. However, the capacity of patients to function is determined not only by what they can do when they exert themselves to the fullest, but also by how they feel when they are carrying out their usual activities of daily living. It is therefore important not only to look at the distance traversed during the unencouraged 6-minute walk but also the symptoms experienced at the end of the effort. To do so, walk distances and Borg Scores from the Week 12 Six-Minute Walk Test were simultaneously compared between treatment groups.
|Study Start Date:||March 2005|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
|SAL Hospital & Medical Institute|
|Narayana Hrudayalaya Inst. Of Cardiac Sciences|
|K. S. Hospital|
|Sri Ramachandra Medical College|
|Medwin Heart Institute|
|Yashoda Super Specialty Hospital|
|Apollo Gleneagles Hospital|
|Kasturba Medical College|
|G. B. Pant Hospital & Maulana Azad Med. College|
|New Delhi, India|
|Ruby Hall Clinic|
|Krishna Institute of Medical Sciences|
|Study Director:||Michael Wade, Ph.D.||United Therapeutics|