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SEACOAST, The Safety and Efficacy of
a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia:
A Dose-Ranging Study
Initiator and Sponsor
Kos Pharmaceuticals, Inc.
Berman Center Site Principal Investigator
Richard H. Grimm, MD, PhD
Berman Center Site Coordinator
Sandra Graham, RN
Description
Niacin and simvastatin are medications that both have been approved
to treat high cholesterol. The purpose of this study is to compare
the effectiveness and safety of a combination of niacin (extended release)
and simvastatin (immediate release), called NS, at different doses,
relative to monotherapy with Zocor.
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TACT, Trial to Assess Chelation Therapy
Sponsors
National Heart, Lung and Blood Institute (NHLBI) and the National Center
for Complementary and Alternative Medicine (NCCAM), U.S. National Institutes
of Health
Principal Investigators
Gervasio A. Lamas, MD, Mt. Sinai Medical Center
Charles H. Hennekens, MD, DrPH, Mount Sinai Medical Center
Berman Center Site Principal Investigator
Richard Grimm, MD, PhD
Berman Center Site Coordinator
Mary Perron, RN, 612-341-7921
Description
This randomized, double-blinded, placebo-controlled trial will enroll
2372 participants at high risk for heart disease. It is a 2x2 factorial:
One factor is chelation therapy vs. placebo, and the other is high-dose
antioxidant vitamin/mineral daily supplements vs. placebo. Participants
are followed for an average of 2.5 years.
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ALLHAT, Anithypertensive and Lipid-Lowering
Treatment to Prevent Heart Attack Trial Sponsor and Initiator
Sponsor
National Heart Lung and Blood Institute (NHLBI), U.S. National Institutes
of Health (NIH)
Region 7 Principal Investigator
Richard Grimm, MD, PhD,
Region 7 and Berman Center Coordinator
Brenda Kirpach, CCRA
Description
ALLHAT, conducted from 1994 to 2002, consisted of 2 trials: one compared
a diuretic with newer antihypertensive drugs to start blood pressure-lowering
treatment; the other compared a statin drug to usual care. The study
was the first one done exclusively in patients with high blood pressure
and involved over 10,000 participants, making it the largest hypertension
clinical trial ever conducted. Findings indicated that less costly,
traditional diuretics work better than newer medicines to treat high
blood pressure and prevent some forms of heart disease.
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AVALON, Evaluation of the Safety and
Efficacy of Dual Therapy with Atorvastatin plus Amlodipine when Compared
to Either Therapy Alone in a Treatment of Patients with Simultaneous
Hyperlipidemia and Hypertension
Sponsor
Pfizer Pharmaceuticals
Berman Center Investigator
Richard Grimm, MD, PhD
Berman Center Site Coordinator
Shirley Conn, RN, 612-341-7909
Description
AVALON enrolled 5 participants with both high blood pressure and high
LDL cholesterol to determine the efficacy of a hypertension agent (Amlodapine),
and a lipid-lowering agent (Atovastatin), either separately or together,
for control of both blood pressure and LDL cholesterol.
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HDFP, Hypertension Detection and Follow-up
Program
Sponsor
National Heart, Lung & Blood Institute (NHLBI), U.S. National Institutes
of Health (NIH)
Berman Center Investigator
Richard Grimm, MD, PhD
Berman Center Site Coordinator
Shirley Conn, RN, 612-341-7909
Description
This national, multi-site study, which was conducted between1971 and
1983, enrolled 10,940 participants aged 30-69 with mild hypertension.
Participants were randomized to 2 treatment arms, were treated for
5 years, and participated in mortality follow-up for 1 year after study
intervention. Based on study results, investigators concluded that
effective treatment of mild hypertension reduces premature deaths by
20%.
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ONTARGET: Ongoing Telmisartan Alone and
in combination with Ramipril Global Endpoint Trial
TRANSCEND: Telmisartan Randomized Assessment Study in ACE Intolerant
Subjects with Cardiovascular Disease
Sponsor
Boehringer Ingelheim Pharmaceuticals, Inc.
Principal Investigator
Salim Yusuf, D. Phil, FRCPC, Canadian Cardiovascular Collaboration
Project Office,
Trial Coordinating Center, McMaster University, Hamilton Ontario, Canada
Berman Center Site Principal Investigator
Richard Grimm, MD, PhD
Berman Center Site Coordinator
Shirley Conn, RN, 612-341-7907
Description
The primary purpose of OnTarget is to compare the efficacy of telmisartan
(an antiotensin II antagonist) and ramipril (an ACE-Inhibitor) either
together or each alone, in reducing the incidence of cardiovascular
disease (CVD) events among individuals at high CVD risk. Using the
same outcomes, TRANSCEND compares telmisartan to placebo for individuals
who are unable to take ACE-Inhibitors because intolerable side effects.
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SHEP, Systolic Hypertension in the Elderly
Sponsor and Initiator
National Heart, Lung & Blood Institute (NHLBI), US National Institutes
of Health (NIH)
Berman Center Site Principal Investigator
Richard Grimm, MD, PhD
Berman Center Site Coordinator
Shirley Conn, RN, 612-341-7907
Description
This national, multi-site study, which was conducted between 1985 and
1991, enrolled 4,736 elderly participants (from 447,921 screenees)
with systolic hypertension. Participants were followed monthly until
SBP reached goal or the maximum level of stepped-care treatment was
received. Average length of follow-up was 4.5 years. Based on study
results, investigators concluded that lowering of systolic blood pressure
through pharmacological therapy reduced the combined rate of fatal
and non-fatal stroke by 36% in men and women 60 years of age and older.
The results of this study changed the treatment of systolic hypertension
for millions of senior citizens. The Berman Center was one of 14 clinical
sites. The Berman Center enrolled 302 participants; 99% of Berman Center
participants completed the trial.
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TOMHS, Treatment of Mild Hypertension
Study
Sponsors
National Heart, Lung & Blood Institute (NHLBI), U.S. National Institutes
of Health (NIH);
Pfizer, Merck, Sharpe, and Dohme
Principal Investigator
Richard H. Grimm, MD, PhD,
Berman Center Site Principal Investigator
John Flack, MD, MPH
Description
This study was a randomized, controlled, double-blind trial with 902
participants conducted at four clinical sites in the U.S. from 1986
to 1992. The study compared the combined effects of diet treatment
and 1 of 5 active drug regimens with diet treatment alone for the long-term
management of mild hypertension (diastolic BP 85-99 mmHg). Study investigators
concluded that nutritional-hygienic therapy is effective in treating
mild hypertension, and that significant blood pressure lowering can
be achieved by adding any one of five different classes of antihypertensive
agents.
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TROPHY, Trial of Preventing Hypertension
Sponsor
Astra-Zeneca
Berman Center Site Principal Investigator
Henry Smith, MD, Hennepin Faculty Associates
Berman Center Site Coordinator
Shirley Conn, RN, 612-341-7907
Description
Individuals with untreated, high-normal blood pressure (130 mmHg ≤ SBP ≤ 139
mmHg and/or 85 mmHg ≤ DBP ≤ 89 mmHg) are believed to be
at elevated risk for developing more severe hypertension and its cardiovascular
disease complications. This multi-site, placebo-controlled, double-blinded
trial investigates the efficacy of Candesartan for lowering blood pressure
in such individuals. |
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