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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. Read our disclaimer for details. Identifier: NCT02279160
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : December 11, 2018
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension
Study Start Date : December 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: APD811
Multiple dose titration to maximum tolerated dose.
Drug: APD811
Other Name: Ralinepag

Placebo Comparator: Placebo
Multiple dose titration to maximum tolerated dose.
Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in pulmonary vascular resistance (PVR) [ Time Frame: Baseline and 22 Weeks ]
    Hemodynamic Effects

  2. Change from baseline in 6-min walk distance (6MWD) in patients with PAH [ Time Frame: Baseline and 22 Weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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:

  • 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

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): NCT02279160

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Sponsors and Collaborators
Arena Pharmaceuticals

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Responsible Party: Arena Pharmaceuticals Identifier: NCT02279160    
Other Study ID Numbers: APD811-003
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: February 2017
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases