NCT00080457

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2003

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

November 9, 2007

Status Verified

November 1, 2007

First QC Date

April 1, 2004

Last Update Submit

November 8, 2007

Conditions

Pulmonary Hypertension

Keywords

Primary or secondary pulmonary arterial hypertensionSclerodermaConnective tissue diseaseCongenital heart defectsLupusPulmonary Arterial Hypertension

Interventions

sitaxsentan sodiumDRUG

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a current diagnosis of symptomatic PAH classified by one of the following:
  • primary pulmonary hypertension (PPH) - also known as idiopathic pulmonary arterial hypertension (IPAH);
  • PAH associated with connective tissue diseases;
  • PAH associated with one of the following congenital heart defects:
  • repaired ASD, VSD or PDA greater than one year post-operative
  • un-repaired secundum ASD (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)
  • World Health Organization (WHO) functional class II, III, IV
  • Greater than 12 and less than 75 years of age
  • Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
  • Have a cardiac catheterization within 6 months before study entry that shows the following values:
  • mean pulmonary artery pressure (PAPm) greater than 25 mmHg (at rest),
  • pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure less than 15 mmHg, and
  • pulmonary vascular resistance (PVR) greater than 3 mmHg/L/min.

You may not qualify if:

  • Portal hypertension or chronic liver disease
  • ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit
  • Contraindication to treatment with an endothelin receptor antagonist
  • Recent history of abusing alcohol or illicit drugs
  • Chronic renal insufficiency
  • Pregnant or breastfeeding
  • Atrial septostomy within 30 days before study entry
  • Previous failure on bosentan because of safety concerns of the lack of clinical response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Encysive Pharmaceuticals

Houston, Texas, 77401, United States

Location

MeSH Terms

Conditions

Hypertension, PulmonaryScleroderma, DiffuseConnective Tissue DiseasesHeart Defects, CongenitalPulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesScleroderma, SystemicSkin and Connective Tissue DiseasesSkin DiseasesCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2004

First Posted

April 5, 2004

Study Start

May 1, 2003

Study Completion

January 1, 2005

Last Updated

November 9, 2007

Record last verified: 2007-11

Locations

US(1)