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Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112487
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:

Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.

To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.


Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Macitentan Phase 3

Detailed Description:
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™
Actual Study Start Date : June 23, 2014
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : September 19, 2018


Arm Intervention/treatment
Experimental: Macitentan
10 mg once daily
Drug: Macitentan
10 mg once daily
Other Name: ACT-064992




Primary Outcome Measures :
  1. To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study. [ Time Frame: Baseline to end of treatment visit (around 6 months on average) ]
    • Treatment-emergent adverse events (AEs)
    • AEs leading to premature discontinuation of study drug
    • Treatment-emergent serious adverse events (SAEs)
    • Proportion of patients with treatment-emergent ALT and/or AST abnormality (> 3, > 5, and > 8 x ULN) associated or not with total bilirubin > 2 x ULN.
    • Proportion of patients with treatment-emergent hemoglobin abnormality (≦ 100 g/L, and ≦ 80 g/L)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to any study-mandated procedure.
  2. Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled
  3. Women of childbearing potential (as defined below) must:

    • Have a negative serum pregnancy test at Visit 1 (i.e., Visit 4 of study AC 055 310) and agree to perform monthly serum pregnancy tests.
    • Agree to use two reliable methods of contraception in parallel, from Visit 1 until 1 month after study drug discontinuation (see details below).

      • A female is considered to have childbearing potential unless she meets at least one of the following criteria:

        • Previous bilateral salpingo and/or oophorectomy, or hysterectomy.
        • Premature ovarian failure confirmed by a specialist.
        • Pre-pubescence, XY genotype, Turner syndrome, uterine agenesis.
        • Postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause.
      • Of the two contraceptive methods that must be used, one must be from Group 1, and one must be from Group 2, defined as follows:

        • Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non-surgical sterilization, e.g., permanent contraception with Essure procedure), or partner's sterilization (vasectomy). If a hormonal contraceptive is chosen from this group, it must be taken for at least one month prior to enrollment. Alternatively, if the Essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations).
        • Group 2: Female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide.
      • Sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study.

Exclusion Criteria:

  1. Patients who prematurely discontinued study drug in study AC-055-310.
  2. Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.
  3. AST and/or ALT more than 3 X ULN.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112487


Locations
Show Show 32 study locations
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Loïc Perchenet Actelion
Additional Information:
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02112487    
Other Study ID Numbers: AC-055-311
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Keywords provided by Actelion:
pulmonary arterial hypertension
PAH-SYMPACT
PAH
psychometric instrument
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists