The Rogosin Institute

One of the foundations of The Rogosin Institute is our commitment to finding new ways to treat or prevent disease. As a result, we are active participants in clinical studies aimed at finding new medicines or preventative measures that will help our patients. We hold ourselves to the highest ethical standards in conducting studies that we believe will advance knowledge and improve the health of patients.

The Rogosin Institutes on-going clinical work is pioneering new treatments in cholesterol disorders. They cover Congential Heart Disease and Cardiomyopathy, Hypercholesterolemia, and Hyperlipidemia.

For more more information about these studies contact:
Susan Spiegel, Development & Public Affairs
212-746-1552

Hypercholesterolemia
Hypercholesterolemia 2
Hyperlipidemia

Hypercholesterolemia

Disease
Hypercholesterolemia

Protocol Title
Gene Polymorphism in Statin-induced Myopothies

Principal Investigator
Bruce Gordon, M.D.

Contact Information: 
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status
Active/Enrollment Open

Brief Summary of Protocol
The purpose of this study is to determine if certain individuals are at a higher risk of developing myopathies while taking statin medications.  The study procedures include a medical history and a detailed history of muscle related symptoms while taking statin medications.  Approximately two teaspoons of blood will be obtained in order to analyze study participant’s DNA to determine if there are any associations between their neuromuscular function and their cholesterol metabolism.  Participation in this study is one day.

Treatment Overview (Potential Benefits)
There is no guaranteed benefit from participating in this study.  Participation in this study may help future patients by providing important information about questions relating to drugs, cardiovascular function, skeletal muscle metabolism and function as well as providing information about genes that have not yet been discovered.

IRB Information
WCMC #07029040
Dr. David Behrman, Chairman
Institutional Review Board
Weill Cornell Medical College
1300 York Avenue, Box #5
New York, NY  10065
               
Sponsor Information
Investigator Initiated
Genomas, Inc.
67 Jefferson Street
Hartford, CT 
860-545-4574
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Hypercholesterolemia 2

Disease
Hypercholesterolemia

Protocol Title
A Phase 2, Open-Label, Dose Escalation Study to Assess the Safety and Efficiency of ISIS 301012 as Add-on-Therapy in Homozygous Familial Hypercholesterolemia Subjects

Principal Investigator
Lisa Hudgins, M.D.

Contact Information
Susan Spiegel, Director of Development & Public Affairs
212-746-1552

Enrollment Status
Completed

Brief Summary of Protocol
The purpose of this study is to test the safety and efficacy of an investigational medication, (not yet approved by the Food & Drug Administration), ISIS 301012 in participants with severe hypercholesterolemia.  Study subjects must already be on a stable dose of lipid-lowering therapies.  There will be four study groups each receiving one of the four graduating doses of the medication.  During the study period, participants will be required to receive a series of eight injections of the study medication in their thigh or abdomen.  On the study drug injection days each participant will also be required to complete a brief physician examination as well as routine blood and urine sampling.  Some visits may require an electrocardiogram and a 24-hour urine collection.  Following the seven-week treatment period participants will be asked to continue with follow-up visits once every three months.

Treatment Overview (Potential Benefits)
There is no guarantee that participants will receive any direct benefit from participation in the study.  Study participants may benefit by having a decrease in their cholesterol levels.  The study may help researchers learn whether ISIS 301012 taken together with therapies currently available for reducing cholesterol is beneficial for people with extremely high cholesterol.

IRB Information    
SA IRB# - 06-01960
Schulman Associates Institutional Review Board
4290 Glendale –Milford Road
Cincinnati, OH  45242
800-557-2472

Sponsor Information
Isis Pharmaceuticals, Inc.
Jill Leonard, Clinical Trials Manager
4620 Wesley Avenue
Cincinnati, OH  45212
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Hyperlipiemia

Disease
Hyperlipiemia

Protocol Title
A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK-0524B (dosed as coadministered MK-0524A and Simvastatin Tablets) versus Atorvastatin in Patients with Mixed Hyperlipidemia.

Principal Investigator
Bruce Gordon, M.D.
 
Contact Information
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status
Complete 

Brief Summary of Protocol
The purpose of this study is to test  the effect of MK-0524B (given as MK-0524A and simvastatin tablets), compared to Atorvastatin alone on blood lipids.  This study also examines the safety and tolerability of the study drug, MK-0524B.  Simvastatin (Zocor®) and Atorvastatin (Lipitor ®) are both FDA approved treatments for high cholesterol.  This study involves seven study visits and participants will be asked to stop taking any previously prescribed cholesterol lowering medication during the study.  Throughout the study the participants will need to maintain a lipid lowering diet and a stable level of exercise.  The study subjects will be assigned to one of six groups with varying strengths and combinations of cholesterol medications and the study medication.  Before each visit the participant will need to fast for 12 hours.  Each visit will include a physical examination and blood and urine sampling.

Treatment Overview (Potential Benefits)
There is no guarantee that subjects will directly benefit from participation in this study.  Blood cholesterol levels of participants may decrease due to the medications but they may also increase as a result of this study.  The information acquired from this study may help other people with Hyperlipidemia in the future.

IRB Information
WIRB Protocol # 20052515
Western International Review Board
3535 7th Avenue, SW
Olympia, WA  98502
800-562-4789/306-252-2500

Sponsor Information
Merck & Co, Inc.
1 Walnut Grove Drive
HM-303
Horsham, PA  19044
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