Clinical Trial: Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-rep

Brief Summary: The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

Detailed Summary: This study is designed as exploratory with the purpose to generate hypotheses on new endpoints
Sponsor: Actelion

Current Primary Outcome:

  • Change from baseline to Week 24 in daily time spent in non-sedentary activity [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    This variable will be assessed by actigraphy and will be expressed in minutes. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in percentage of daily time spent in non-sedentary activity [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    This variable will be assessed by actigraphy and is expressed in percentage. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in total daily life physical activity [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    This variable will be assessed by actigraphy and is expressed in counts per minute. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in total sleep time (TST) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    TST (in minutes) will be assessed by actigraphy. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in wake after sleep onset (WASO) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    Same as current

    Current Secondary Outcome:

    • Change from baseline to Week 24 in World Health Organization Functional Class (WHO FC) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      The change from baseline in WHO FC will be classified into "Improved", "No change" and "Worsened". The change from baseline in WHO FC will be displayed in a shift table with percentage of participants in each category at Week 24
    • Change from baseline to Week 24 in 6-minute walk distance (6MWD) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      The 6MWD is the total distance walked during 6 minutes. Mean change from baseline (distance walked at Week 24 minus distance walked at baseline) will be calculated
    • Change from baseline to Week 24 in Borg dyspnea score [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      The Borg dyspneas score is a self-rating scale to evaluate the severity of dyspnea (from 0 "no breathlessness at all" to 10 "very, very severe / maximal"). It will be completed immediately after the 6-minute walk test at Week 24 and at baseline. Mean change from baseline in scoring will be calculated
    • Change from baseline to Week 24in N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      Mean change from baseline in blood concentration of NT-proBNP (value at Week 24 minus value at baseline) will be calculated
    • Change from baseline to Week 24 in cardiovascular symptom domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24 to assess PAH-specific symptoms and their physical and cognitive/emotional impact. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined
    • Change from baseline to Week 24 in cardiopulmonary symptom domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined
    • Change from baseline to Week 24 in physical impact domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined
    • Change from baseline to Week 24 in cognitive/emotional impact domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
      PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined


    Original Secondary Outcome: Same as current

    Information By: Actelion

    Dates:
    Date Received: March 6, 2017
    Date Started: June 1, 2017
    Date Completion: November 1, 2018
    Last Updated: May 11, 2017
    Last Verified: May 2017