Clinical Trials

A RANDOMIZED, MULTICENTER STUDY OF FIRST-LINE AMBRISENTAN AND TADALAFIL COMBINATION THERAPY IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PROTOCOL NUMBER: GS-US-300-0140

AMBITION

Status: open and enrolling

Approval Date: 3/13/2012

Objective: Primary objective is to compare the two treatment strategies: first line combination therapy: ambrisentan AND tadalafil)  VS first line monatherapy: ambrisentan OR tadalafil in subjects with PAH.   Safety and tolerability will also be compared.

This study is to test how well the drugs ambrisentan and tadalafil work together to treat Pulmonary Arterial Hypertension [PAH] (a narrowing of the arteries connecting the lungs to the heart that leads to an increase in blood pressure) 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. 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.

A Randomized multicenter study of first-line ambrisentan and tadalafil combination therapy in subjects with pulmonary arterial hypertension protocol number GS-US-300-0140

Status: open and enrolling

Approval Date: 3/13/2012

Primary objective is to compare the two treatment strategies:  first line combination therapy:  ambrisentan AND tadalafil VS. first line monotherapy:  ambrisentan OR tadalafil in subjects with pulmonary hypertension.  Safety and tolerability will also be compared.

A post marketing observational study to assess respiratory tract adverse events in pulmonary arterial hypertension patients treated with Tyvaso inhalation solution

Status: open and enrolling

Approval Date: 10/19/2011

Tyvaso is an inhaled drug recently approved in the United States for treatment of pulmonary arterial hypertension (PAH).  Researchers want to better understand the long-term safety of this drug compared to other therapies for PAH.  Information about your current drug treatment as normally prescribed by your doctor and certain reactions to the drug treatments will be recorded into the registry.  The objective of this study is to describe the type and frequency of pulmonary adverse events that may be associated with certain treatments for PAH.

Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative Extension Program

Status: open and enrolling

Approval Date: 10/13/2011

To improve the management of PAH patients through evidence-based approach aimed at achieving optimal WHO functional class.  This study is seeking patients with a specific condition, pulmonary arterial hypertension.

MEDTRONIC SURESCAN PACING SYSTEM POST APPROVAL STUDY

Status: open and enrolling

Approval Date: 10/7/2011

Objective: Chronic Performance Arm - Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months.

Multiple MRI Scan Arm - Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic's standard of care.

Description: The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval. This study is part of the Product Performance Platform (PPP).