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Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
sitaxsentan sodium
Sponsored by
ICOS-Texas Biotechnology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: NYHA Class II, III or IV 16 to 75 years of age Specific peak VO2 range PPH, PAH due to connective tissue disease or select congenital heart disease Qualifying cardiac catheterization History of CXR and qualifying pulmonary function test History of qualifying ventilation-perfusion lung scan History of qualifying echocardiogram Women of childbearing potential must use contraceptives Stable dose of corticosteroids if prescribed Exclusion Criteria: Significant lung disease Chronic liver disease Uncontrolled sleep apnea History of specific types of left heart disease Any disorder that compromises ability to give informed consent Uncontrolled sleep apnea Inability to perform bicycle exercise test On-going treatment with an experimental drug or device within the last 30 days HIV infection Specific liver dysfunction Chronic renal disease Pregnancy/Nursing Chronic active hepatitis B or C Chronic Flolan or Tracleer use within the last 30 days

Sites / Locations

  • University of Southern California Hospital, Ambulatory Health Sciences
  • University of California, San Francisco
  • Harbor-UCLA Medical Center
  • The Children's Hospital
  • University of Colorado/ Health Science Center
  • Emory University Hospital - McKelvey Lung Transplantation Center
  • Medical College of Georgia
  • Dekalb Medical Center
  • Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center
  • LSU - School of Medicine
  • Maine Medical Center
  • John Hopkins Hospital
  • Massachusetts General Hospital
  • University of Michigan Hospital, Division of Cardiology
  • Mayo Clinic - Division of Cardiovascular Disease
  • Columbia Presbyterian Medical Center
  • Duke University Medical Center
  • The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care
  • Division of Cardiology - The Ohio State University Medical Center
  • Oregon Health Sciences
  • University of Pittsburgh Medical Center, CHF/Transplantation Cardiology
  • Pulmonary Division - Rhode Island Hospital
  • Vanderbilt University Medical Center
  • Baylor College of Medicine Pulmonary & Critical Care Section
  • University of Wisconsin Medical School
  • SMBD Jewish General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 24, 2002
Last Updated
June 23, 2005
Sponsor
ICOS-Texas Biotechnology
Collaborators
ICOS Corporation, Texas Biotechnology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00034307
Brief Title
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
Official Title
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ICOS-Texas Biotechnology
Collaborators
ICOS Corporation, Texas Biotechnology Corporation

4. Oversight

5. Study Description

Brief Summary
This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sitaxsentan sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NYHA Class II, III or IV 16 to 75 years of age Specific peak VO2 range PPH, PAH due to connective tissue disease or select congenital heart disease Qualifying cardiac catheterization History of CXR and qualifying pulmonary function test History of qualifying ventilation-perfusion lung scan History of qualifying echocardiogram Women of childbearing potential must use contraceptives Stable dose of corticosteroids if prescribed Exclusion Criteria: Significant lung disease Chronic liver disease Uncontrolled sleep apnea History of specific types of left heart disease Any disorder that compromises ability to give informed consent Uncontrolled sleep apnea Inability to perform bicycle exercise test On-going treatment with an experimental drug or device within the last 30 days HIV infection Specific liver dysfunction Chronic renal disease Pregnancy/Nursing Chronic active hepatitis B or C Chronic Flolan or Tracleer use within the last 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyn Frumkin, M.D., Ph.D.
Organizational Affiliation
ICOS Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California Hospital, Ambulatory Health Sciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Colorado/ Health Science Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Emory University Hospital - McKelvey Lung Transplantation Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Dekalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
LSU - School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Hospital, Division of Cardiology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic - Division of Cardiovascular Disease
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Division of Cardiology - The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health Sciences
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Pittsburgh Medical Center, CHF/Transplantation Cardiology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pulmonary Division - Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine Pulmonary & Critical Care Section
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Medical School
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
SMBD Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.phassociation.org
Description
Pulmonary Hypertension Association

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Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

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