Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT02279160

Run by

United Therapeutics

People needed

61

Starts

2014-12-01

Expected to finish

2017-06-01

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UCLA Medical Center — Torrance, California, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Maryland — Baltimore, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• UT Southwestern — Dallas, Texas, United States
• University of Texas, Houston Center for Clinical and Translational Sciences — Houston, Texas, United States
• The Prince Charles Hospital — Chermside, Australia
• St Vincent's Hospital — Darlinghurst, Australia
• St Vincent's Hospital — Fitzroy, Australia
• Royal Hobart Hospital — Hobart, Australia
• Fiona Stanley Hospital — Murdoch, Australia
• "Многопрофилната болница за активно лечение "Национална кардиологична болница "" ЕАД — Sofia, Bulgaria
• Многопрофилна болница за активно лечение "Света Анна" София АД, Клиника по кардиология — Sofia, Bulgaria
• II. interní klinika - klinika kardiologie a angiologie, 1. lékařská fakulta, Univerzita Karlova v Praze a Všeobecná fakultní nemocnice v Praze — Prague, Czechia
• Gottsegen György Országos Kardiologiai Intézet, Felnőtt Kardiológia — Budapest, Hungary
• Semmelweis Egyetem Pulmonológiai Klinika — Budapest, Hungary
• Pécsi Tudományegyetem Klinikai Központ, Szívgyógyászati Klinika — Pécs, Hungary
• Uniwersytecki Szpital Kliniczny w Białymstoku — Bialystok, Poland
• Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie — Krakow, Poland

Full record on ClinicalTrials.gov

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