Pulmonary HypertensionPhase 2/3NCT00034307
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
A Phase 2/3 study testing sitaxsentan sodium in people with Pulmonary Hypertension, run by ICOS-Texas Biotechnology at 26 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- sitaxsentan sodium
- How many people
- 180 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- History of qualifying ventilation-perfusion lung scan
- History of qualifying echocardiogram
- Women of childbearing potential must use contraceptives
- Stable dose of corticosteroids if prescribed
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
University of Michigan Hospital, Division of Cardiology
Ann Arbor, Michigan, 48109
Emory University Hospital - McKelvey Lung Transplantation Center
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912
John Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care
Cleveland, Ohio, 44195
Division of Cardiology - The Ohio State University Medical Center
Columbus, Ohio, 43210
Dekalb Medical Center
Decatur, Georgia, 30033
The Children's Hospital
Denver, Colorado, 80218
University of Colorado/ Health Science Center
Denver, Colorado, 80262
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine Pulmonary & Critical Care Section
Houston, Texas, 77030
University of Southern California Hospital, Ambulatory Health Sciences
Los Angeles, California, 90033
University of Wisconsin Medical School
Milwaukee, Wisconsin, 53215
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
LSU - School of Medicine
New Orleans, Louisiana, 70112
Columbia Presbyterian Medical Center
New York, New York, 10032
University of Pittsburgh Medical Center, CHF/Transplantation Cardiology
Pittsburgh, Pennsylvania, 15213
Maine Medical Center
Portland, Maine, 04102
Oregon Health Sciences
Portland, Oregon, 97201
Pulmonary Division - Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic - Division of Cardiovascular Disease
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
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.
- Conditions
- Pulmonary Hypertension
- Being tested
- sitaxsentan sodium
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitaxsentan sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- ICOS-Texas Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation, Texas Biotechnology Corporation
- Investigators
- Lyn Frumkin, M.D., Ph.D., Study director, ICOS Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034307
- Sponsor's protocol ID
- FPH01/FPH01-X
- Status last verified
- May 2002
- First submitted
- 24 Apr 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00034307
- Acronym / sponsor ID
- FPH01/FPH01-X
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants
- Lead sponsor
- ICOS-Texas BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation, Texas Biotechnology Corporation
- First posted
- 25 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sitaxsentan sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Pulmonary Hypertension AssociationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyn Frumkin, M.D., Ph.D. study director
ICOS Corporation
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sitaxsentan sodium in people with Pulmonary Hypertension, run by ICOS-Texas Biotechnology at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.