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Clinical Research

The Hypertension Institute strives to offer our patients access to the latest clinical research, medications, and technology in the treatment of hypertension and cardiovascular disease. In support of this mission, we have conducted clinical trials on site for major pharmaceutical companies such as Forest, AstraZeneca, Daiichi Sankyo, Solvay, Takeda, Sanofi-Aventis, Boehringer Ingelheim, Novartis, Merck and others, as well as research in the areas of nutraceuticals supplements with companies such as Biotics Research, Designs For Health and AC Grace. Many of these trials have produced groundbreaking data on the treatment of hypertension such as ALLHAT, CONVINCE, INVEST, ACCOMPLISH, AGELESS, and others. Besides contributing to the growing body of knowledge, these trials provide our patients with access to promising medications before they are approved for the marketplace.

The care is at no cost to the patient and most patients benefit from the close monitoring by our physicians and research staff.Our research staff is composed of a professional group of study coordinators who are dedicated to clinical research. These coordinators have over 30 years of research expertise in cardiovascular disorders such as hypertension, coronary artery disease, anti-aging depression, diabetes, and dyslipidemia. All patients’ rights and care are protected by federal mandates, which are strictly adhered to in research protocols.

Clinical Studies

  1. Evaluation of Antihypertensive Therapy. (Clonidine vs Propranolol) On Glucose Tolerance in the Hypertensive Patient with Diabetes Mellitus. Vanderbilt University Medical Center (1980-1983). (B.I.L. Grant) Published in part in Cardiology Clinics 14:117-135, February, 1986.
  2. Evaluation of Atrovent in Chronic Obstructive Pulmonary Disease. Vanderbilt University Medical Center (1980-1983) (B.I.L. Grant).
  3. Evaluation of CL 115, 347 (Prostaglandin E). An Oral and Transdermal Prostaglandin Antihypertensive as Monotherapy in Combination with Hydrochlorothiazide in Mild to Moderate Hypertensive Patients, Vanderbilt University Medical Center (1984). (Completed). (Lederle Grant). (No publication. Drug withdrawn from clinical trails). Co-investigators: Dr. John Nadeau and Dr. Alastair Wood in Clinical Pharmacology SCOR.
  4. Evaluation of Antihypertensive Therapy (Clonidine and Atenolol) on Serum Lipids, Apoproteins and HDL Subfractions and Glucose in Mild Essential Hypertension. Vanderbilt University Medical Center (1984-1990), (Completed). (B.I.L. Grant). Co-investigators: Dr. John Nadeau, Dr. Taylor Hays, Dr. Larry Swift, Dr. Charles Bradley, Clinical Pharmacology, SCOR and Department of Pathology. (Abstract Published in American Federation of Clinical Research, January, 1987.) Manuscript published in American Heart Journal, 1990; 120:172-179.
  5. Evaluation of Clonidine and Yohimbine on Plasma Volume, Sodium Excretion and Clinical Symptoms in Mitral Valve Prolapse Autonomic Dysfunction and Normals. Vanderbilt University Medical Center. (No publication). Co-investigators: Dr. David Robertson and Dr. Jack Onrot, Clinical Pharmacology.
  6. Retrospective Analysis of Medical Consult Service. Vanderbilt Hospital (1982-1984). Published in Southern Medical Journal 80:176-180, December 1987. Co-investigators: Dr. Taylor Hays, Dr. Frank Gluck and Dr. David Ratcliff.
  7. Evaluation of Regression of Left Ventricular Hypertrophy in Mild to Moderate Hypertension with Various Antihypertensive Agents. Clinical Study with the Division of General Internal Medicine, Division of Cardiology, SCOR in Hypertension and Critical Care Unit, Vanderbilt Medical Center, American Heart Association Grant). Co-investigators: Dr. Marvin Kronenberg, Dr. John Nadeau and Dr. Ben Byrd, Clinical Pharmacology, SCOR and Cardiology.
  8. Comparison of Mild, Moderate and Severe Hypertensive Patients in Cooperative Care Center Versus University Hospital Patients: Effects of an Education Program on Patient Compliance and Blood Pressure Control. (Completed). Co-investigators: Beth Pulliam, R.N. and Kathy Gibson, R.N. (Abstract published: National Council on High Blood Pressure, 1989).
  9. The Effects of Topical Minoxidil in Untreated Mild Hypertensive Patient. Vanderbilt University Medical Center. (Completed). (Upjohn Grant). (Multicenter study to be published). Co-investigator: Dr. John Nadeau, Clinical Pharmacology and SCOR.
  10. Pharmacokinetics of Bepridil in Patient with Ischemic Heart Disease: Comparison of Single Versus Multiple Dose Kinetics. (Drug withdrawn from clinical trials). (No publication). Co-investigator: Dr. Ray Woosley.
  11. Effect of Guanabenz on Natriuretic Hormone and Atrial Natriuretic Factor in Patients with Essential Hypertension. (Wyeth Grant).
  12. Comparative Effects of Nifedipine, Atenolol and Placebo on Serum Lipids, Lipoproteins, Lipid Subfractions and Glucose in Mild Hypertensive Patients. (Pfizer Grant). Co-investigator: Dr. Mike Lichtenstein. (Abstract published in ASH Meetings, AFCR and International College of Angiology 1990).
  13. Clinical Evaluation of Clonidine, Hydrochloride and Catapres-TTS in Smoking Cessation (1987). (B.I.L. Grant). Co-investigators: Dr. Craig Heim and Dr. Mike Lichtenstein, Division of General Internal Medicine.
  14. Effect on Glucose Tolerance with Hydrochlorothiazide or Angiotensin Converting Enzyme Inhibitor Monotherapy Captopril and Mechanism of Antidiabetic Effect in Hypertensive Patients with Diabetes Mellitus (1986). Co-investigator: Dr. Taylor Hays. (Squibb Grant).
  15. Open Evaluation of the Efficacy and Safety of Wytensin (Guanabenz) Administered Orally in the Treatment of Hypertensive Type II Diabetic Outpatients. (Wyeth Pharmaceuticals Grant).
  16. An Evaluation of Efficacy of Wytensin (Guanabenz) when Added to Non-Excellent Responders to Dyazide with Mild to Moderate Hypertension. (Wyeth Pharmaceuticals Grant).
  17. Comparative Effects of Captopril, Thiazide Diuretics, and Placebo on Serum Lipids, Lipoproteins, Lipid Subfractions, Glucose, Potassium and Quality of Life in Mild to Moderate Hypertensive Patients. (Squibb Grant).
  18. Comparative Study of Clarithromycin and Penicillin VK in the Treatment of Patients with Streptococcal Pharyngitis. (Abbott Labs Grant). Co-investigator: Dr. Mark Jacokes.
  19. Effect of Catapres-TTS in Alcohol Withdrawal and Chronic Abstinence. (B.I.L. Grant 1988). Principal Investigator: Dr. Peter Martin. Co-investigators: Dr. Mark Houston and Dr. Anderson Spickard.
  20. Dose Response Evaluation of Diltiazem.in Patients with Hypertensive Urgency. (Marion Labs Grant).
  21. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Clinical Study to Determine the Dose-Response Relationship to Diltiazern Extended Release (ER) in Patients with Mild to Moderate Hypertension. Merck, Sharp and Dohme Research Laboratories 1989.
  22. Catapres-TTS and Procardia XL in the Treatment of Mild Hypertension. (B.I.L. Grant, 1990).
  23. Quinapril Monotherapy Clinical Trial in Mild to Moderate Hypertension.
  24. Double-Blind, Placebo-Controlled, Dose Titration Study of the Safety and Efficacy of Dilacor XR in Elderly Patients with Mild to Moderate Hypertension. Rhone-Boulenc Rorer Grant 1992.
  25. Insomnia Treatment Study Comparing Triazolam and Temazepam. Upjohn Grant 1992.
  26. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Nonsteroidal Anti-Inflammatory Drugs (NSAID’s) on Blood Pressure in Patients with Mild to Moderate Hypertension Controlled by Verelan. Wyeth Ayerst Grant 1992.
  27. HOT Study. Hypertension Optimal Treatment International Study. Astra Merck.
  28. A Multicenter, Prospective, Randomized, Controlled, Double-Blind Study Examining the Effects of Substituting Norvasc for Procardia XL in the Treatment of Essential Hypertension. Pfizer.
  29. ALLHAT Study (NHLIB). Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial. University of Texas.
  30. Double-Blind, Randomized, Multicenter Trial Comparing Once-Daily Verelan Versus Norvasc in Women with Mild to Moderate Essential Hypertension. Lederle Laboratories, Wyeth Ayerst Laboratories.
  31. A Triple-Blind Parallel Study to Investigate the Effect of Losartan Versus Atenolol on the Reduction of Morbidity and Mortality in Hypertensive Patients with Left Ventricular Hypertrophy. Merck & Company, Inc.
  32. RESOLVD. Randomized Evaluation of Strategies for Left Ventricular Dysfunction. Pilot Study. A Two Staged Randomized Trial of Candesartan, Enalapril, and Metoprolol in Patients with Congestive Heart Failure. Canadian Cardiovascular Council.
  33. TARKA. Trandolapril in Hypertension: Effectiveness When Added to Verapamil SR. Knoll Pharmaceutical Company.
  34. A-TIME Study. Accupril Titration Interval Management Evaluation. Parke-Davis.
  35. A Comparison of the Safety and the Efficacy of Mibefradil and Amiodipine in Hypertensive, Non-Diabetic Patients and Hypertensive, Non-Insulin Dependent Diabetic Patients. Roche Pharmaceuticals.
  36. A 54-Week Open Label Assessment of the Safety and Efficacy Profile of Atorvastatin as Compared to Simvastatin when Used to Optimally Control Patients with Mixed Dyslipidemia. Parke-Davis.
  37. A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Measuring the Effects of Cl-991 on Non-insulin Dependent Diabetes Mellitus (NIDDM) Patients Requiring Insulin. Parke-Davis.
  38. A Randomized, Double-Blind, Parallel Trial Comparing Lotrel 5/10 mg. Once Daily, Lotrel 5/20 mg. Once Daily, Nifedipine GITS 30 mg. Once Daily, and Nifedipine GITS 60 mg. Once Daily in Patients Age 18-80 Years with Essential Hypertension Inadequately Controlled with Nifedipine ITS 30 mg. Once Daily Followed by a Single-Blind Extension of Lotrel 5/20 mg. Once Daily. CIBA.
  39. CONVINCE. Clinical Protocol for Controlled Onset Verapamil Investigation of Cardiovascular Endpoints. Searle & Company.
  40. TROPHY. A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Long-Term Trial of Preventing Hypertension Using Candesartan Cilexetil 16 mg in Patients with High Normal Blood Pressure. Astra Pharmaceuticals, L.P.
  41. INVEST. International Verapamil-SR Trandolapril Study. Knoll.
  42. A Randomized, Double-Blind, Active-Controlled Study of the Antihypertensive Response to Omapatrilat in Subjects Uncontrolled on ACE-Inhibitor Therapy. Bristol-Myers Squibb.
  43. BELLES. Beyond Endorsed Lipid Lowering with EBT Scanning. Pfizer.
  44. Evaluation of Coronary Heart Disease Regression by EBT in Patients Treated with Concentrated Fruit and Vegetable Extracts. National Safety Associates.
  45. OCTAVE. Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril. Bristol-Myers Squibb.
  46. AVALON. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled and Open-Label Evaluation of the Safety and Efficacy of Dual Therapy with Atorvastatin Plus Amlodipine when Compared to Either Therapy Alone in the Treatment of Patients with Simultaneous Hyperlipidemia and Hypertension. Pfizer.
  47. STARS. A Multi-Center, Open-Label, 12-Week Study to Evaluate the Glycemic Control Achieved in StarLix 120 mg in Subjects with Type 2 Diabetes Mellitus in a Practice-Based Setting. Novartis.
  48. PRESERVE. A Multi-Center, Randomized, Double-Blind, Active Controlled Trial to Compare the Efficacy and Safety of 104 Weeks of StarLix (Nateglinide) Plus Metformin vs. Glyburide Plus Metformin in Drug Naïve Subjects with Type 2 Diabetes Mellitus who have Inadequate Glycemic Control with Diet and Exercise. Novartis.
  49. Hypertension Formula Study. A 40 Subject, Placebo-Controlled Trial to Compare the Efficacy of Vasatrol vs. Placebo.
  50. Hypertension Natural Treatment Vasatrol II Study. A 12 Subject Trial.
  51. CCOX 189A2332. An International, Multi-Center, Stratified, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 52-Week Gastrointestinal Clinical Safety Study to Demonstrate that COX 189 (400 mg od) Reduces the Risk to Develop Complicated Ulcers as Compared to NSAID’s (Naproxen 500 mg bid and Ibuprofen 800 mg tid) in Osteoarthritis Patients. Novartis.
  52. A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients with Mild to Moderate Hypertension. Bertek Pharmaceuticals, Inc.
  53. EASE. A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/day when Added to Ongoing Therapy with a Statin Versus Statin Therapy Alone in Patients with Hypercholesterolemia who have not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III LDL-Cholesterol Level. Merck & Co., Inc.
  54. ADHERE. A Multi-Center, Randomized, Double-Blind, Double-Dummy Study Evaluating the Safety and Efficacy of the Addition of Amlodipine to Quinapril or Losartan in the Treatment of Diabetic Hypertensive Subjects. Pfizer Pharmaceuticals Inc.
  55. Aliskiren. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparing Aliskiren 150 mg, 300 mg, and 600 mg to Placebo and Irbesartan 150 mg in Patients with Mild to Moderate Essential Hypertension. Novartis Pharmaceuticals Corp.
  56. A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Forced Titration, Comparison of Micardis HCTZ (Telmisartan 80 mg/HCTZ 25 mg) Versus Diovan HCTZ (Valsartan 160 mg/HCTZ 25 mg) Using Seated Trough Cuff Blood Pressure in Patients with Stage 1 and Stage 2 Hypertension. Boehringer Ingelheim Pharmaceuticals.
  57. A Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan (320 mg) and HCTZ (12.5 and 25 mg) Combined and Alone, Valsartan 160 mg and Valsartan 160 mg/HCTZ 12.5 mg in Hypertensive Patients. Novartis.
  58. ACCOMPLISH. A Prospective, Multi-National, Multi-Center, Double-Blind, Randomized, Active-Controlled Trial to Compare the Effects of Lotrel to Benazapril and HCTZ Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients with High Risk Hypertension. Novartis.
  59. A Multi-Center, Randomized, Double-Blind Study to Compare the Effects of 24-Weeks Treatment with LAF237 (50 mg QD, 50 mg BID or 100 mg QD) to Placebo in Drug Naïve Patients with Type 2 Diabetes. Novartis.
  60. A Multi-Center, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24-Weeks Treatment with LAF237 (50 mg QD or BID) to Placebo as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy. Novartis.
  61. A Multi-Center, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24-Weeks Treatment with LAF237 (50 mg QD or BID) to Placebo as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Thiazolidinedione Monotherapy. Novartis.
  62. Oral Ribose in the Treatment of Statin-Induced Myalgias 30 Patient Study. Bioenergy, Inc.
  63. Oral Ribose in the Treatment of Statin-Induced Myalgias 50 Patient Study. Bioenergy, Inc.
  64. Evaluation of a Tocotrienol Complex on Serum Lipids in Human Subjects. Designs for Health.
  65. A Double-Blind, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy and Safety of TAK-475 and Simvastatin Alone and in Combination in Subjects with Hypercholesterolemia. Takeda.
  66. A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 or Placebo When Co-Administered with Fenofibrate in Subjects with Combined Hyperlipidemia. Takeda.
  67. Plasma Renin Activity as a Physiologic Marker for the Selection of Appropriate Anti-Hypertensive Drug Therapy in Patients Unsuccessfully Treated on Multiple Drugs: The Laragh Method. Cardiovascular Center at the New York Presbyterian Hospital Cornell Medical Center and Weill Medical Center.
  68. AGELESS. A 36-Week, Randomized, Double-Blind, Parallel Group, Multi-Center, Active-Controlled, Optimal Titration Study Comparing an Aliskiren-Based Regimen to a Lisinopril-Based Regimen in Patients > 65 Years Old with Systolic Essential Hypertension. Novartis.
  69. LIPIDSIRT Study: 2 month evaluation of 40 patients with dyslipidemia. Biotics.
  70. Insomnia Study: One month evalution of 40 patients with chronic insomnia with a nutritional supplement
  71. Hypertension Study: Evaluation of CardioSirt BP in Hypertension patients: Biotics Research