Long Term Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:12/9/2018
Start Date:July 2015
End Date:September 2019

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An Open-Label Extension Study of APD811-003 in Patients With Pulmonary Arterial Hypertension

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.


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- Patients who enrolled in APD811-003 and were withdrawn from study drug treatment due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
We found this trial at
5
sites
Dallas, Texas 75390
Phone: 214-645-6487
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Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-4433
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Phone: 617-638-4344
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Boston, MA
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Columbus, Ohio 43210
Phone: 614-366-2287
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Columbus, OH
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Darlinghurst, 2010
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Darlinghurst,
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