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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:12/22/2018
Start Date:November 8, 2017
End Date:June 28, 2019

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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-reported Symptoms and Their Impacts

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.

This study is designed as exploratory with the purpose to generate hypotheses on new
endpoints

Inclusion Criteria:

- Male or female between 18 and 75 years old inclusive.

- Women of childbearing potential must have a negative serum pregnancy test at planned
visits and use an acceptable method of birth control from screening up to 30 days
after study treatment discontinuation.

- Symptomatic pulmonary arterial hypertension (PAH) belonging to one of the following
subgroups only:

- Idiopathic

- Heritable

- Drug or toxin induced

- Associated with one of the following: connective tissue disease; HIV infection;
corrected simple congenital heart disease.

- With the following hemodynamic characteristics assessed by right heart catheterization
(RHC) prior to randomization:

- Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg

- Pulmonary vascular resistance (PVR) ≥ 240 dyn•sec/cm5 (or 3 Wood Units)

- Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure
(LVEDP) ≤ 15 mmHg.

- Treatment with an endothelin receptor antagonist (ERA) for at least 90 days and on a
stable dose for 30 days prior to randomization.

- If an ERA is given in combination with a phosphodiesterase-5 (PDE-5) inhibitor or
soluble guanylate cyclase (sGC) stimulator, these treatments must be ongoing for at
least 90 days and on a stable dose for 30 days prior to randomization.

- WHO functional class (FC) II or III at randomization

- 6-minute walk distance (6MWD) ≥ 100 m at screening.

- Ability to walk without a walking aid.

- Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®.

Exclusion Criteria:

- Patients on a PAH-specific monotherapy targeting the nitric oxide pathway (i.e. PDE-5
inhibitor or sGC stimulator).

- Patients treated with prostacyclin, prostacyclin analog or selexipag within 3 months
prior to screening.

- Any hospitalization during the last 30 days prior to screening.

- Severe coronary heart disease or unstable angina.

- Documented severe hepatic impairment or severe renal insufficiency at screening.

- Participation in a cardio-pulmonary rehabilitation program based on exercise training
within 8 weeks prior to screening

- Any factor or condition likely to affect full participation in the study or compliance
with the protocol (such as adherence to protocol mandated procedures), as judged by
the investigator.
We found this trial at
8
sites
1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Phone: 404-236-8113
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Phone: 617-636-4288
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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300 Meadowmont Village Circle
Chapel Hill, North Carolina 27599
Phone: 919-966-2531
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Chapel Hill, NC
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-2042
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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1 Fadingerstraße
Linz, 4020
Phone: +43 732 7676 4916
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Linz,
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100 West Market Street
Louisville, Kentucky 40202
Phone: 502-587-8000
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Louisville, KY
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259 1st Street
Mineola, New York 11501
Phone: 516-663-9582
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Mineola, NY
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Torrance, California 90502
Phone: 310-222-3560
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Torrance, CA
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