A Randomized, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension, “Ambition” Trial

A Randomized, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension, “Ambition” Trial
Recruiting
18 years - 75 years
All
Phase 3
100 participants needed
1 Location

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 description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: ambition trial,pulmonary arterial hypertension,pulmonary arterial hypertension (PAH)
  • Age: 18 years - 75 years
  • Gender: All


Updated on 19 Feb 2024. Study ID: 812736

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