Selexipag (ACT-293987) in Pulmonary Arterial Hypertension, GRIPHON Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01106014
First received: April 2, 2010
Last updated: September 25, 2014
Last verified: September 2014

April 2, 2010
September 25, 2014
December 2009
September 2014   (final data collection date for primary outcome measure)
Time to first adjudicated morbidity or mortality event (up to 7 days after last study-drug intake) [ Time Frame: Baseline (day 1) to over a period of up to 4.3 years ] [ Designated as safety issue: Yes ]

defined as

  • Death or
  • Hospitalization for worsening of PAH or
  • Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy or
  • Initiation of parenteral prostanoid therapy or chronic oxygen therapy or
  • Disease progression
Demonstrate the effect of ACT-293987 on time to first clinical worsening in pts. with PAH. Clinical worsening is delineated according to the definition of the Dana Point 4th World Symposium of PH McLaughlin VV. et al. JACC 2009; 54 (S1): S97-S107 [ Time Frame: Baseline (day 1) to over a period of up to 3.5 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01106014 on ClinicalTrials.gov Archive Site
Evaluate the effect of ACT-293987 on exercise capacity (6-minute walk distance & Borg dyspnea index) & other secondary & exploratory efficacy endpoints in patients with PAH [ Time Frame: Baseline (day 1) to over a period of up to 4.3 years ] [ Designated as safety issue: Yes ]
Evaluate the effect of ACT-293987 on exercise capacity (6-minute walk distance & Borg dyspnea index) & other secondary & exploratory efficacy endpoints in patients with PAH [ Time Frame: Baseline (day 1) to over a period of up to 3.5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Selexipag (ACT-293987) in Pulmonary Arterial Hypertension, GRIPHON Trial
A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

The AC-065A302 GRIPHON study is an event-driven Phase 3 study to demonstrate the effect of ACT-293987 on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Selexipag (ACT-293987)
    tablets, twice daily
    Other Name: Selexipag (ACT-293987)
  • Drug: Placebo
    tablet, matching placebo, twice daily
    Other Name: Placebo
  • Active Comparator: 1
    Selexipag (ACT-293987), twice daily
    Intervention: Drug: Selexipag (ACT-293987)
  • Placebo Comparator: 2
    Matching placebo, twice daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1156
October 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients 18-75 years old, with symptomatic PAH
  • PAH belonging to the following subgroups of the updated Dana Point Clinical Classification Group 1 (Idiopathic, or Heritable, or Drug or toxin induced, or Associated (APAH) with Connective tissue disease, Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV infection)
  • Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at any time prior to Screening
  • Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks prior to the Baseline Visit
  • Signed informed consent

Exclusion Criteria:

  • Patients with pulmonary hypertension (PH) in the Updated Dana Point Classification Groups 2-5, and PAH Group 1 subgroups that are not covered by the inclusion criteria.
  • Patients who have received prostacyclin or its analogs within 1 month before Baseline Visit, or are scheduled to receive any of these compounds during the trial.
  • Patients with moderate or severe obstructive lung disease
  • Patients with moderate or severe restrictive lung disease
  • Patients with moderate or severe hepatic impairment (Child-Pugh B and C).
  • Patients with documented left ventricular dysfunction
  • Patients with severe renal insufficiency.
  • Patients with BMI <18.5 Kg/m2.
  • Patients who are receiving or have been receiving any investigational drugs within 1 month before the Baseline Visit.
  • Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6MWT Recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training.
  • Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
  • Life expectancy less than 12 months.
  • Females who are lactating or pregnant or plan to become pregnant during the study.
  • Known hypersensitivity to any of the excipients of the drug formulations.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Ukraine,   Hungary,   Romania,   Poland,   Germany,   Serbia,   Korea, Republic of,   Denmark,   Netherlands,   India,   United States,   China,   Russian Federation,   Israel,   Argentina,   Spain,   Chile,   Turkey,   Australia,   Colombia,   Czech Republic,   United Kingdom,   Canada,   France,   Peru,   Switzerland,   Malaysia,   Mexico,   Italy,   Taiwan,   Sweden,   Ireland,   Austria,   Belarus,   Singapore,   Slovakia,   Greece,   Thailand,   Belgium
 
NCT01106014
AC-065A302
Yes
Actelion
Actelion
Not Provided
Study Director: Aline Frey Actelion
Actelion
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP