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Clinical Trials

Complexa is currently enrolling participants into two Phase 2 clinical trials.

Snapshot Overview of FIRSTx Clinical Trial in FSGS

For more information about FIRSTx, visit: firstx-trial.com

 

 

 

What is PAH?

Pulmonary arterial hypertension (PAH) is a progressive disorder characterized by high pressure (hypertension) in the arteries of the lungs (pulmonary artery) for unknown reason. Symptoms of PAH include shortness of breath (dyspnea), especially during exercise, chest pressure and fatigue. Current treatment options primarily reduce the symptoms associated with the high pressure by dilating the vessels that carry blood from the right side of the heart to the lungs. The ability to modify the underlying disease is an important treatment goal for the next generation of products.

 

What is the PRIMEx Clinical Trial?PRIMEx is a Phase 2 clinical study testing the safety and effectiveness of an investigational drug called CXA-10 designed to treat patients with PAH who are on stable background therapy. Throughout the study, researchers will evaluate how different doses of CXA-10 affect the patient’s quality of life as well as how CXA-10 is absorbed and excreted. The study is taking place at approximately 50 clinical sites across the United States and the United Kingdom. The study will enroll up to 115 patients who have been diagnosed with PAH.

Am I eligible to participate in the PRIMEx Clinical Trial?

The PRIMEx study is open to individuals who meet the following criteria:*

  • Women and men between the ages of 18 and 80 

  • Have been diagnosed with PAH (WHO Group 1) 

  • Meet hemodynamic criteria by means of a right heart catheterization

  • Meet pulmonary function test parameters and 6MWD range

  • Receiving treatment with no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonist (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists and must be on stable doses (≥3 months) 

 

*Additional criteria will be used to determine participation

 

Before enrolling, your doctor will go over all of the details of the trial, including the possible risks and benefits.

 

For more information about PRIMEx, visit clinicaltrials.gov (NCT 03449524).

 

What is a Clinical Trial?

Researchers conduct clinical studies to help discover new and better ways to treat and prevent specific diseases. Studies are possible because of patients like you. Before new treatments can be made publicly available, the U.S. Food and Drug Administration (FDA) requires that they are studied in clinical trials. Choosing to join a clinical study is an important personal decision. There are possible benefits and risks associated with clinical studies. Talk with your doctor and family members or friends before deciding to enroll. It is your decision whether to participate and you can choose to stop taking part in.

 

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