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Endothelin Receptor Antagonist

Sitaxsentan for Pulmonary Arterial Hypertension

Phase 2 & 3
Waitlist Available
Research Sponsored by ICOS-Texas Biotechnology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA Class II, III or IV
16 to 75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new medication, sitaxsentan, for the treatment of pulmonary arterial hypertension. The study will compare the safety and effectiveness of two different doses of sitaxsentan to placebo. Patients who complete the trial may be eligible to participate in an extension trial.

Who is the study for?
This trial is for people aged 16-75 with pulmonary arterial hypertension, who are in NYHA functional class II to IV. They must have had certain heart and lung tests, be able to do a bicycle exercise test, and if they're women who can have children, use contraception. People with significant lung or liver disease, uncontrolled sleep apnea, certain heart conditions, or those on recent experimental treatments cannot join.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of sitaxsentan at two different doses versus a placebo in treating pulmonary arterial hypertension over 12 weeks. Participants who finish may continue in an extension trial where everyone gets sitaxsentan.See study design
What are the potential side effects?
Potential side effects of sitaxsentan could include issues related to liver function (like jaundice), fluid retention leading to swelling (edema), headaches, nasal congestion or stuffiness (rhinitis), nausea or upset stomach.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe heart condition symptoms.
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I am between 16 and 75 years old.
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I have high blood pressure in the lungs due to a specific heart condition or connective tissue disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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Who is running the clinical trial?

ICOS-Texas BiotechnologyLead Sponsor
ICOS CorporationIndustry Sponsor
25 Previous Clinical Trials
14,001 Total Patients Enrolled
Texas Biotechnology CorporationIndustry Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Sitaxsentan (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT00034307 — Phase 2 & 3
Pulmonary Hypertension Research Study Groups:
Pulmonary Hypertension Clinical Trial 2023: Sitaxsentan Highlights & Side Effects. Trial Name: NCT00034307 — Phase 2 & 3
Sitaxsentan (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00034307 — Phase 2 & 3
Pulmonary Hypertension Patient Testimony for trial: Trial Name: NCT00034307 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I possibly participate in this clinical trial?

"This particular research is seeking to enroll 180 individuals that suffer from pulmonary hypertension. The age requirement for potential candidates is 16-75 years old. Additionally, women of childbearing potential must use contraceptives."

Answered by AI

Does this research project allow for patients that are middle-aged or older?

"Individuals aged 16 to 75 that meet the other inclusion criteria may qualify for this particular clinical trial. There are 59 other trials seeking patients under 18 and 708 recruiting people over 65."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Dekalb Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried other medications and my BP is still not under control.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
2024. "Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00034307.
All > Pulmonary Arterial Hypertension > Pulmonary Hypertension
~120 spots leftby Apr 2025
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