CompletedPhase 2

Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Belgium, China76 participantsStarted 2015-02-03

Plain-language summary

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Who can participate

Age range18 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: * Written informed consent * Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24). * Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception. Exclusion Criteria: * Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities. * Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With AEs Leading to Study Drug Discontinuation

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Hemoglobin Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Liver Tests Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Change From Baseline in Blood Pressure at Month 6

Timeframe: Baseline and Month 6

Change From Baseline in Pulse Rate at Month 6

Timeframe: Baseline and Month 6

Trial details

NCT IDNCT02060721

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-21

Results submitted2023-03-17

View on ClinicalTrials.gov More Chronic Thromboembolic Pulmonary Hypertension trials

Who can participate

Age range18 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.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With AEs Leading to Study Drug Discontinuation

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Hemoglobin Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Liver Tests Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Change From Baseline in Blood Pressure at Month 6

Timeframe: Baseline and Month 6

Change From Baseline in Pulse Rate at Month 6

Timeframe: Baseline and Month 6