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: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Selexipag (ACT-293987)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1156
Study Start Date: December 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Selexipag (ACT-293987), twice daily
Drug: Selexipag (ACT-293987)
tablets, twice daily
Other Name: Selexipag (ACT-293987)
Placebo Comparator: 2
Matching placebo, twice daily
Drug: Placebo
tablet, matching placebo, twice daily
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106014

  Show 182 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Aline Frey Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01106014     History of Changes
Other Study ID Numbers: AC-065A302
Study First Received: April 2, 2010
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Austria: Ethikkommission
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada
Chile: Comité de Ética Científico
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
India: Drugs Controller General of India
India: Institutional Review Board
Ireland: Irish Medicines Board
Ireland: Research Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Instituto Nacional de Salud
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Pharmacological Committee, Ministry of Health
Serbia: Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Slovak Republic: Ethics Committee
Slovakia: State Institute for Drug Control
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Switzerland: Swissmedic
Switzerland: Ethikkommission
Taiwan: Department of Health
Taiwan: Institutional Review Board
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Turkey: Ethics Committee
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Actelion:
pulmonary arterial hypertension
PAH

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014