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Trial record 1 of 2 for:    ralinepag
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Long Term Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Arena Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02279745
First received: October 25, 2014
Last updated: February 4, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Pulmonary Arterial Hypertension
Drug: APD811
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of APD811-003 in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 60
Study Start Date: July 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APD811 Drug: APD811
Other Name: Ralinepag

  Eligibility

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

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
  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: NCT02279745

Contacts
Contact: Brian L Raether 858-210-3644 braether@arenapharm.com
Contact: Maya Zimmermann, Ph.D +41 62 746 75 75 mzimmermann@arenapharm.com

Locations
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      
Australia
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
Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie, Sectia Clinica Pneumologie II Recruiting
Timisoara, Romania, 300310
Spain
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
  More Information

Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02279745     History of Changes
Other Study ID Numbers: APD811-007
Study First Received: October 25, 2014
Last Updated: February 4, 2017

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

ClinicalTrials.gov processed this record on May 24, 2017