CompletedPhase 3

Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

151 participantsStarted 2006-01

Plain-language summary

The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222) * Signed informed consent Exclusion Criteria: * Any major violation of protocol AC-052-366 (NCT00313222) * Pregnancy or breast-feeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance

Timeframe: Until discontinuation of study drug, up to 3.3 years

Change From Baseline to All Assessed Time Points in Borg Dyspnea Index

Timeframe: Until discontinuation of study drug, up to 3.3 years

Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)

Timeframe: Until discontinuation of study drug, up to 3.3 years

Time to Clinical Worsening up to End-of-study

Timeframe: Until discontinuation of study drug, up to 3.3 years

Trial details

NCT IDNCT00319111

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-02

Results submitted2012-05-24

View on ClinicalTrials.gov More Pulmonary Hypertension trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance

Timeframe: Until discontinuation of study drug, up to 3.3 years

Change From Baseline to All Assessed Time Points in Borg Dyspnea Index

Timeframe: Until discontinuation of study drug, up to 3.3 years

Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)

Timeframe: Until discontinuation of study drug, up to 3.3 years

Time to Clinical Worsening up to End-of-study

Timeframe: Until discontinuation of study drug, up to 3.3 years