A Randomized, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension, “Ambition” Trial
Brief Description Of Study
This clinical research study involves an experimental combination of two drugs, ambrisentan and tadalafil for the treatment of Pulmonary Arterial Hypertension (a narrowing of the arteries connecting the lungs to the heart that leads to an increase in blood pressure). This is also known as PAH. These drugs have been approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of PAH. However, the combination of ambrisentan and tadalafil has not been previously studied and approved by the FDA. FDA Clinical
Detailed Study Description
PAH greatly increases the workload of the right side of the heart and over time may lead to dizziness, difficulty breathing, chronic fatigue, right heart failure, and possibly death. There is no cure for PAH at this time. You may have heard of ambrisentan and tadalafil. You may also know these drugs as Letairis or Adcirca. These drugs are used to treat PAH. This study is testing the combined use of these two drugs. Tadalafil is part of a group of drugs called phosphodiesterase type-5 (PDE-5) inhibitors. Ambrisentan is one of a group of drugs called endothelin receptor antagonists (ERAs). These drugs work through different pathways to improve blood flow to the lungs. The purpose of this study is to test how well the drugs ambrisentan and tadalafil work together to treat PAH compared to ambrisentan or tadalafil alone. We want to find out what effects, good or bad, they have on people with PAH. We also want to see how safe these drugs are when used together.