A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.

Phase 1

• Conditions: Pulmonary Arterial Hypertension; MedDRA version: 18.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-000667-40-ES
• Lead Sponsor: Arena Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-09
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-Males or females aged 18-75 years, inclusive
-Symptomatic WHO Group 1 PAH classified by one of the following subgroups:
*Idiopathic PAH (IPAH)
*Heritable PAH (HPAH)
*Drugs and toxins induced
*Associated with PAH (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 on stable oral disease-specific PAH therapy with either an ERA and/or an agent acting on the nitric oxide pathway, i.e. a PDE-5 inhibitor or a soluble guanlyate 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 differnt 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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 the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified