Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study was conducted as a placebo-controlled, randomized, 22-week double-blind study which included a dose titration period. An additional transition period occurred for those patients who elected to enroll into the open-label extension study, APD811-007. A total of 61 patients with PAH were enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals; United Therapeutics

Criteria

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 pulmonary arterial hypertension (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