Clinical Trials

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.

A CLINICAL OUTCOMES STUDY TO COMPARE THE EFFECT OF FLUTICASONE FUROATE/VILANTEROL INHALATION POWDER 100/25MCG WITH PLACEBO ON SURVIVAL IN SUBJECTS WITH MODERATE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND A HISTORY OF OR AT INCREASED RISK FOR CARDIOV

Protocol HZC113782 A Phase III, randomized, double-blind, parallel-group, multi-center study evaluating FF/VI 100/25mcg, each component individually, and placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease and a history of or increased risk for cardiovascular disease.

Status: closed

Approval Date: 10/10/2011

Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality.  Study data suggests the possibility of an ICS/LABA combination product to be of substantial benefit in COPD subjects with less severe airflow obstruction yet with increased cardiovascular risk.

The mechanism by which SFC appears to be associated with a greater reduction in mortality in these less severe COPD subjects with concomitant cardiovascular comorbidities is speculative at present, but could potentially in part be related to a lessening of the degree of inflammation in the systemic circulation, potential plaque stabilization and/or amelioration of arterial stiffness.

The primary objective of this study is to prospectively evaluate the effect of Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25mcg QD compared with placebo on survival in subjects with moderate COPD  and a history of, or at an increased risk for developing, cardiovascular disease.

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).

CTSU CALGB 70807: THE MEN'S EATING AND LIVING (MEAL) STUDY: A RANDOMIZED TRIAL OF DIET TO ALTER DISEASE PROGRESSION IN PROSTATE CANCER PATIENTS ON ACTIVE SURVEILLANCE

Status: open and enrolling

Approval Date: 9/29/2011

This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.

SWOG S1007 A PHASE III RANDOMIZED CLINICAL TRIAL OF STANDARD ADJUVANT ENDOCRINE THERAPY +/- CHEMOTHERAPY IN PATIENTS WITH 1-3 POSITIVE NODES HORMONE RECEPTOR-POSITIVE AND HER-2 NEGATIVE BREAST CANCER WITH RECURRENCE SCORE (RS) OF 25 OR LESS

Status: open and enrolling

Approval Date: 8/30/2011

This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer.