Clinical trial NCT02060721: Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Official title: MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2014-02-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: Number of Participants With Hemoglobin Abnormalities
timeFrame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
measure: Number of Participants With Liver Tests Abnormalities
timeFrame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
measure: Change From Baseline in Blood Pressure at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Pulse Rate at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Body Weight at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
city: Beijing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Wuhan
country: China
city: Praha 2
country: Czechia
city: Le Kremlin-Bicetre Cedex
country: France
city: Paris Cedex 15
country: France
city: Toulouse Cedex 9
country: France
city: Giessen
country: Germany
city: Heidelberg
country: Germany
city: Würzburg
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Kaunas
country: Lithuania
city: Ciudad de Mexico
country: Mexico
city: Lublin
country: Poland
city: Wroclaw
country: Poland
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Zürich
country: Switzerland
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Capa_Istanbul
country: Turkey
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Cambridge
country: United Kingdom
city: London
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Actelion
name: Erin McGuire
role: STUDY_DIRECTOR
References: