Clinical Trials

Beaumont Health System, with three hospitals in the northern Detroit suburbs serving southern Michigan and beyond, is a highly productive contributor to clinical trials across the nation. The Beaumont Research Institute, established by the hospital’s Board of Trustees in 1966, strengthens Beaumont's ability to conduct medical research and to provide a research training experience for the medical staff and participants in graduate medical education programs.

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, ACTIVE REFERENCE, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF A 10-DAY TWICE DAILY ORAL ADMINISTRATION OF 3 DOSES OF ACT-179811 IN SUBJECTS WITH CLOSTRIDIUM DIFFICILE INFECTION (CDI)-

ACT-179811 in Patients With Clostridium Difficile Infection (CDI)

Status: closed

Approval Date: 4/2/2012

To evaluate the effectiveness of treatment for patients with Clostridium difficile infection (CDI).


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.


CTSU ECOG E1609: A PHASE III RANDOMIZED STUDY OF ADJUVANT IPILIMUMAB ANTI-CTLA4 THERAPY VERSUS HIGH-DOSE INTERFERON A-2B FOR RESECTED HIGH-RISK MELANOMA

Status: open and enrolling

Approval Date: 3/9/2012

RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective then interferon alfa-2b in treating patients with melanoma.   PURPOSE: This phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery.


A STUDY TO EVALUATE RENALGUARD SYSTEM SAFETY AND EFFICACY WHEN COMPARED WITH STANDARD CARE IN THE PREVENTION OF CONTRAST INDUCED NEPHROPATHY IN THE SETTING OF A CATHETERIZATION LABORATORY-[PROTOCOL RGS001D]

Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients (CIN-RG)

Status: open and enrolling

Approval Date: 3/8/2012

Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.