SEACOAST, The Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia: A Dose-Ranging StudyInitiator and Sponsor
Kos Pharmaceuticals, Inc.
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.
TACT, Trial to Assess Chelation Therapy
National Heart, Lung and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), U.S. National Institutes of Health
This randomized, double-blinded, placebo-controlled trial will enroll 2372 participants at high risk for heart disease. It is a 2×2 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.
ALLHAT, Anithypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Sponsor and Initiator
National Heart Lung and Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)
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.
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
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.
HDFP, Hypertension Detection and Follow-up Program
National Heart, Lung & Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)
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%.
ONTARGET: Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial
TRANSCEND: Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease
Boehringer Ingelheim Pharmaceuticals, Inc.
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.
SHEP, Systolic Hypertension in the Elderly
Sponsor and Initiator
National Heart, Lung & Blood Institute (NHLBI), US National Institutes of Health (NIH)
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.
TOMHS, Treatment of Mild Hypertension Study
National Heart, Lung & Blood Institute (NHLBI), U.S. National Institutes of Health (NIH);
Pfizer, Merck, Sharpe, and Dohme
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.
TROPHY, Trial of Preventing Hypertension
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.