Bayer has launched a Phase 4 clinical trial called REPLACE to evaluate Adempas (riociguat) in patients with pulmonary arterial hypertension (PAH) who do not respond properly to treatment with certain inhibitors such as Revatio (sildenafil) or Adcirca (tadalafil).
The study is also sponsored by Merck, and is expected to enroll 218 PAH patients at 26 sites in the U.S. and a total of 100 study sites worldwide.
“Bayer is committed to improving the lives of patients living with pulmonary arterial hypertension through ongoing research that addresses important clinical questions on how to manage the disease,” Aleksandra Vlajnic, MD, Bayer’s vice president of medical affair, said in a news release. “This study will help improve our understanding of therapeutic choices and how they may impact these patients.”
The REPLACE trial (NCT02891850) is an international, open-label study which aims to assess whether PAH patients can effectively and safely switch from a treatment with PDE-5 inhibitors to Adempas, used alone or combined with an endothelin receptor antagonist (ERA). Results will be compared to those in patients who maintain their treatment regimen.
The effectiveness of Adempas will be evaluated according to whether patients do not experience worsening symptoms and improve in two of three different parameters, such as an increase in the six-minute walk distance test (6MWD, a measure of exercise capacity; 10 percent or more, or 30 meters or more), disease severity (WHO functional class 1 or 2), and a decrease in the levels of a biomarker of PAH called NT-proBNP by at least 30 percent.
The study will not include patients with other forms of pulmonary hypertension in addition to PAH; those who have been previously treated with Adempas; and those who have other clinically significant lung diseases.
According to results of the Phase 3 trial PATENT-1 (NCT00810693) and the open-label extension trial PATENT-2 (NCT00863681), PAH patients treated with Adempas had an improved exercise capacity, pulmonary vascular resistance, and disease severity.
Adempas was approved by the U.S. Food and Drug Administration as a treatment for PAH (WHO groups 1 and 4). The drug acts by stimulating the activity of an enzyme called soluble guanylate cyclase. Previous preclinical studies have shown that Adempas promotes antifibrotic, antiproliferative and anti-inflammatory molecular mechanisms.
For more information about the trial and how to participate, please visit this link.
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