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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014