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Long Term Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT02279745
Recruitment Status : Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : December 7, 2018
Sponsor:
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
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 : September 2019
Estimated Study Completion Date : September 2019


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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02279745


Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43221
United States, Texas
University of Texas, Southwestern
Dallas, Texas, United States, 75390
Australia
St Vincent's Hospital
Darlinghurst, Australia, 2010
St. Vincent's Hospital
Fitzroy, Australia, 3065
Fiona Stanley Hospital
Murdoch, Australia, 6150
Bulgaria
Multiprofile Hospital for Active Treatment " St. Anna", Sofia AD, Cardiology Clinic
Sofia, Bulgaria, 1750
Czechia
Department of Internal Medicine I - Cardiology, University Hospital Olomouc
Olomouc, Czechia, 77900
Second Internal Clinic - Clinic of Cardiology and Angiology, 1st Faculty of Medicine, Charles University in Prague, General University Hospital in Prague
Prague, Czechia, 12808
Hungary
University of Pecs, Medical School, Heart Institute
Pécs, Hungary, 7624
Poland
Medical University of Bialystok Clinical Hospital
Białystok, Poland, 15-276
Romania
"Marius Nasta" Institute of Pneumoftiziology, Department of Pneumoftiziology IV
Bucharest, Romania, 050159
"Dr. Victor Babes" Clinic Hospital for Infesctious Diseases and Pneumoftiziology, Department of Clinic Pneumology II
Timisoara, Romania, 300310
Serbia
Clinical Centre of Serbia (CCS), Cardiology Clinic
Belgrade, Serbia, 11000
Clinical Hospital Centre (CHC) Zemun, Clinic for Internal Medicine, Cardiology Department
Belgrade, Serbia, 11080
Institute of Pulmonary Diseases of Vojvodina Sremska Kamenica (IPDVSK), The Clinic for Urgent Pulmonology, ICU - Intensive Care Unit
Sremska Kamenica, Serbia, 21204
Spain
Clinic Hospital of Barcelona, Department of Pneumology
Barcelona, Spain, 11000
Hospital 12th of October, Department of Cardiology
Madrid, Spain, 28041
Sponsors and Collaborators
Arena Pharmaceuticals

Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02279745     History of Changes
Other Study ID Numbers: APD811-007
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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