Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02279160
• Date of registration: 25/10/2014
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension
• Scientific title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: December 2014
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02279160
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Bulgaria, Czech Republic, Czechia, Hungary, Poland, Romania, Serbia, Spain, United States

Contacts

• Name: Derek Solum, PhD
• Affiliation: United Therapeutics

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: APD811

Drug: Placebo

Primary Outcome(s)

Change From Baseline in 6-minute Walk Distance (6MWD) in Patients With PAH [Time Frame: Baseline and 22 Weeks]

Change From Baseline in Pulmonary Vascular Resistance (PVR) [Time Frame: Baseline and 22 Weeks]

Secondary ID(s)

APD811-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02279160