Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:12/13/2018
Start Date:December 2014
End Date:June 2017

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A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension

The study will be conducted as a placebo-controlled, randomized, 22 week double-blind study
which will include a dose titration period. An additional transition period will occur for
those patients who elect to enroll into the open-label extension study, APD811-007.
Approximately 60 patients with PAH will be enrolled.


Inclusion Criteria:

- Males or females aged 18-75 years, inclusive

- Symptomatic WHO Group 1 PAH classified by one of the following subgroups:

- Idiopathic pulmonary arterial hypertension (IPAH);

- Heritable pulmonary arterial hypertension (HPAH);

- Drugs and toxins induced;

- Associated with (APAH); specifically connective tissue diseases, HIV infection
and congenital heart disease

- Has had the diagnosis of PAH confirmed by cardiac catheterization

- Has WHO/NYHA functional class II- IV symptomatology

- Previously diagnosed with PAH and on stable oral disease-specific PAH therapy with
either an ERA and/or an agent acting on the nitric oxide pathway, i.e. a PDE5
inhibitor or a soluble guanylate cyclase stimulator. Stable is defined as no change in
dose within 3 months of the start of Screening and for the duration of the study

- Has 6MWT distances of 100-500 m, and within 15% of each other on 2 consecutive tests
done on different days at Screening

- Has pulmonary function tests (PFTs) within 6 months prior to the start of Screening
with no evidence of significant parenchymal lung disease

- Has a ventilation-perfusion (V/Q) lung scan or pulmonary angiogram within 5 years
prior to Screening and concomitant with or following diagnosis of PAH that shows no
evidence of thromboembolic disease

- If on vasodilators (including calcium channel blockers), digoxin, spironolactone, or
L-Arginine supplementation; the patient must be on a stable dose for at least 1 month
prior to the start of Screening

Exclusion Criteria:

- Newly diagnosed with PAH and on no disease-specific PAH therapy

- Previous participation in any clinical study with an investigational drug, biologic,
or device within 2 months prior to the Screening visit

- Acutely decompensated heart failure within 1 month prior to start of Screening

- Systolic blood pressure <90 mm Hg at Screening

- Evidence or history of left-sided heart disease and/or clinically significant cardiac
disease

- Use or chronic administration (defined as >30 days) of a prostacyclin or prostacyclin
analogue within 3 months of Screening

- Any previous use of a prostacyclin or prostacyclin analogue that was stopped for
safety or tolerability issues associated with pharmacology/mechanism of action

- 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
13
sites
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-384-8005
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-975-9964
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-248-7134
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Sacramento, California 95814
Phone: 916-734-1554
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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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Baltimore, MD
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Phone: 617-638-4860
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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Chermside, 4032
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-3257
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Columbus, Ohio 43210
Phone: 614-366-2287
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Dallas, Texas 75390
Phone: 214-645-6487
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Pittsburgh, Pennsylvania 15260
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Torrance, California 90509
Phone: 310-222-3560
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