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

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:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

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 ]

Estimated Enrollment:	1150
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 203 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:	May 3, 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: L’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 May 16, 2013