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 range18 Years – 80 Years

SexALL

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

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

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