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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Hypertension (High Blood Pressure)

Trial Information

This research study is being done to compare the effects of three different approved drugs for high blood pressure in patients that have type 2 diabetes and who are taking medications for high blood pressure to determine the effect of each approved blood pressure drug on blood sugar levels.

Your participation in this study will last for approximately 7 months. You will first be evaluated to determine if you meet the criteria for the study. This is done by asking you questions about your medical history and medications you are currently taking, by testing your blood, and by a physical examination. If you meet the criteria, you will stop all of your hypertension medications except for one for a 2 week time period. After 2 weeks you will be assigned to one of the 3 FDA approved medications. The treatment assignment will be done at random (like the flip of a coin). Neither you nor your doctor will know which medication you have been assigned. Your dose of medication will be reached by following your blood pressure levels and increasing the dose if necessary over 10 weeks. If your blood pressure is well-controlled, you will continue on the medication for an additional 16 weeks. If after 10 weeks your blood pressure is not well controlled, then your doctor may give you an additional FDA approved drug for blood pressure control and you will continue in the program for an additional 16 weeks. During the course of the study, you will need to return to the study center about twice a month for blood pressure measurements, and on a few occasions, you will be instructed to not eat or drink (except for water) the night before your study visit and until after your blood is drawn. You will not be charged for any of the study visits or medications. If you would like to be considered for participation in this study, you should contact one of the participating research centers listed.

INCLUSION CRITERIA:

• Male or female, 18 - 85 years of age
• Blood pressure in the range of 130 to 179/80 to 109 mmHg
• Currently using at either an ACE inhibitor or an ARB alone or (an ACE inhibitor or an ARB and up to two other drugs for treatment of high blood pressure). (Patients may be on both an ACE inhibitor and ARB, but would need to be taken off one.)
• Stable medication regimen for high blood pressure for at least one month prior to screening
• Stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin
• HgbA1c 6.5 to 8.5% (This is measured at the screening visit)

EXCLUSION CRITERIA:

• Use of any beta blocker within one month prior to screening
• Use of clonidine within 3 months prior to screening
• Diagnosis of hyperthyroidism as evidenced by abnormal lab markers
• Any disorder requiring the intermittent or chronic use of systemic corticosteroids
• Presence or history of thyroid disease, unless on treatment for hypothyroidism and stable for at least 3 months
• Active liver disease as determined by lab markers
• Kidney impairment; estimated GFR < 60 mL/min/1.73 m2
• History of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or TIA in 3 months prior to screening
• Chronic heart failure
• Drug or alcohol abuse within 2 years prior to screening
• History of sensitivity to any beta blocker, HCTZ, sulfa drug, or calcium channel blocker
• Participation in another research study within 30 days prior to screening

Jamie Kelsey, Study Coordinator
North Alabama Research Center, LLC
108 Sanders St, Suite C
Athens, AL 35611
Phone: 256-771-9919
Fax: 256-771-2026
EMail: jkelsey_narc@bellsouth.net

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