Long Term Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02279745
Recruitment Status : Recruiting
First Posted : October 31, 2014
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
This study is an open-label extension study to determine the long-term safety and tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2 study, APD811-003. Patients must have completed the APD811-003 study and must meet eligibility criteria for APD811-007.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: APD811 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of APD811-003 in Patients With Pulmonary Arterial Hypertension
Study Start Date : July 2015
Estimated Primary Completion Date : December 2017

Arm Intervention/treatment
Experimental: APD811 Drug: APD811
Other Name: Ralinepag

Primary Outcome Measures :
  1. Long-term safety assessed by AEs and SAEs up to 28 days following discontinuation of the study drug. [ Time Frame: 28 days following discontinuation of the study drug. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document
  • Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and is deemed an appropriate candidate for participation in a long-term extension study and administration of APD811

    • Fulfilled all eligibility criteria for APD811-003 and completed the study as planned
    • Patients who discontinued for clinical worsening in APD811-003 and were assigned to placebo and completed all end of study procedures including right heart catheterization (RHC) may participate after their data from the APD811-003 study is cleaned and locked

Exclusion Criteria:

  • Patients who enrolled in APD811-003 and were withdrawn from study drug treatment due to any AE, SAE, or clinical worsening if assigned to APD811, or patients who did not complete the APD811 003 study for other reasons.
  • Female patients who wish to become pregnant
  • Systolic BP <90 mmHg at Baseline/Day 1
  • Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02279745

Contact: Brian L Raether 858-210-3644
Contact: Maya Zimmermann, Ph.D +41 62 746 75 75

United States, Alabama
University of Alabama, Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Deborah Weber    205-975-9969      
Contact: Leigh Powell    205-975-9859      
United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Kristen Alman    916-734-1554      
UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Joy Beckman    310-222-3560      
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Page Scovel    319-384-8005      
Contact: Cynthia Larew         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Faith Pa'ahana Brown    410-328-4433      
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Fei-Ying Cheong, PhD, MA    617-638-4344      
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 43221
Contact: Melissa Banuelos    513-558-3257      
Ohio State University medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Janice Drake    614-366-2287      
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15229
Contact: Jessica Pisarcik    614-366-2287      
United States, Texas
University of Texas, Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Jacqeline Quivers    214-645-6487      
University of Texas, Houston Center for Clinical and Translational Sciences Recruiting
Houston, Texas, United States, 77030
Contact: Stacy Burk    713-500-6851      
Contact: Mary Ayad    713-500-7484      
The Prince Charles Hospital Recruiting
Chermside, Australia, 4032
St Vincent's Hospital Recruiting
Darlinghurst NSW, Australia, 2010
Royal Hobart Hospital Recruiting
Hobart, Australia, 7000
Fiona Stanley Hospital Recruiting
Murdoch, Australia, 6150
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie, Sectia Clinica Pneumologie II Recruiting
Timisoara, Romania, 300310
Hospital Clinic de Barcelona, Departamento de Pneumologia Recruiting
Barcelona, Spain, 11000
Hospital 12 de Octubre, Departamento de Cardiologia Recruiting
Madrid, Spain, 28041
Sponsors and Collaborators
Arena Pharmaceuticals

Responsible Party: Arena Pharmaceuticals Identifier: NCT02279745     History of Changes
Other Study ID Numbers: APD811-007
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

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