“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     Site Principal Investigator: Richard Grimm, MD, MPH, 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. At the end of 28 weeks of blinded treatment, participants could opt to participate in an open-label extension of 64 weeks, when they would receive both medications together, in one tablet.   Role of the Berman Center     The Berman Center enrolled 5 participants between May 2001 and June 2002. During the double-blinded period of 28 weeks, participants attended the Berman Center for study visits every two months. One participant was eligible for the open-label extension, which requires a study visit to the Berman Center every 28 weeks. At each study visit, Berman Center doctors and research nurses completed blood pressure monitoring, blood tests, electrocardiograms, arterial compliance measurements, and physicals. All Berman Center participants completed the main part of the study by January 2003; the one Berman Center participant enrolled in the open-label extension completed the study in February 2004.   Abstract     Many hypertensive individuals also have hyperlipidemia, and vice versa. It is unknown if treatment for hypertension confers an additional benefit in reduced cholesterol, or if treatment for hyperlipidemia confers an additional benefit in reduced blood pressure. The possibility of controlling both conditions in a single medication also has been explored. The study was designed as a randomized, double-blinded, 2x2 factorial in which one factor is treatment with Amliodipine (5 mg initial dose vs. placebo), and the other factor is treatment with Atorvastatin (10 mg initial dose vs. placebo). No participants were randomized to receive the placebo-placebo combination, resulting in a 3-arm trial (Amliodipine alone, Atorvastatin alone, Amliodpine and Atorvastatin together). A total of 1,000 participants were enrolled in 150 sites across the U.S. between Spring 2001 and September 2002; each participant was treated and followed for at least 28 weeks. Study medications were titrated to achieve SBP ≤ 130 mmHg, DBP ≤ 80 mmHg, and LDL cholesterol ≤ 100 mg/dL. Blood pressure and cholesterol measurements were taken every two months after randomization for 28 weeks.