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PORtopulmonary Hypertension Treatment wIth maCitentan ─ a randOmized Clinical Trial (PORTICO)

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ClinicalTrials.gov Identifier: NCT02382016
Recruitment Status : Completed
First Posted : March 6, 2015
Results First Posted : November 22, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

Condition or disease Intervention/treatment Phase
Portopulmonary Hypertension Drug: Macitentan Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension
Actual Study Start Date : June 23, 2015
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Macitentan

Arm Intervention/treatment
Experimental: Investigational treatment
Macitentan film-coated tablet 10 mg once daily.
Drug: Macitentan
Macitentan film-coated tablet 10 mg once daily.
Other Name: ACT-064992

Placebo Comparator: Placebo
Matching placebo tablet once daily.
Other: Placebo
Matching placebo tablet once daily.




Primary Outcome Measures :
  1. Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR). [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    The relative change from baseline to Week 12 in PVR is expressed as a ratio of Week 12 to baseline PVR.


Secondary Outcome Measures :
  1. Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD) [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

  2. Change From Baseline to Week 12 in WHO Functional Class (FC) [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    Changes from baseline to Week 12 in WHO FC were dichotomized as worsening (i.e., change > 0) versus no change or improvement (i.e., change ≤ 0). Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest (e.g. dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure.

  3. Change From Baseline to Week 12 in the Biomarker N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    NT-proBNP functions as a strong indicator of prognosis in patients with pulmonary hypertension (PH). The relative change from baseline to Week 12 in NT-proBNP is expressed as a ratio of Week 12 to baseline NT-proBNP.

  4. Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    mRAP is the mean blood pressure in the right atrium of the heart.

  5. Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP) [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    mPAP is the mean blood pressure inside the pulmonary artery which moves the blood from the heart to the lungs. Monitoring of mPAP can detect small changes in the function of the heart.

  6. Change From Baseline to Week 12 in Cardiac Index [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    The cardiac index is an assessment of the function of the heart and relates the cardiac output to the patient's body size (the patient's body surface area).

  7. Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR) [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    TPR is the resistance the pulmonary circulation that must be overcome in order for the blood flow to occur. It takes into account the blood pressure in the pulmonary arteries and the cardiac output. It is an important measurement to monitor the function of the pulmonary circulation and detect disease progression or improvement.

  8. Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SVO2) [ Time Frame: From enrollment/baseline to Week 12 in the DB treatment period ]
    SVO2 help assess tissue oxygen delivery. It describes the percentage of oxygen bound to hemoglobin in the blood which returns to the heart. This reflects the amount of residual oxygen in the blood after oxygen extraction by the tissues throughout the body.



Information from the National Library of Medicine

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

Main Inclusion Criteria:

  • Male or female of at least 18 years of age
  • Confirmed diagnosis of portopulmonary hypertension

Main Exclusion Criteria:

  • Severe hepatic impairment
  • Severe obstructive or restrictive lung disease
  • Pulmonary veno-occlusive disease
  • Systolic blood pressure (SBP) < 90 mmHg at Screening
  • ALT/AST >= 3 x ULN
  • Bilirubin >= 3 mg/dL at Screening
  • Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results

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): NCT02382016


  Show 52 Study Locations
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Loïc Perchenet, PhD Actelion
  Study Documents (Full-Text)

Documents provided by Actelion:
Study Protocol  [PDF] April 21, 2016
Statistical Analysis Plan  [PDF] February 6, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02382016     History of Changes
Other Study ID Numbers: AC-055-404
First Posted: March 6, 2015    Key Record Dates
Results First Posted: November 22, 2018
Last Update Posted: January 9, 2019
Last Verified: December 2018

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists