Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

Completed · Phase 4

Conditions studied: Hypertension, Type 2 Diabetes Mellitus

In brief

This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus

Key facts

Study ID

NCT00744237

Run by

Forest Laboratories

People needed

231

Starts

2008-08-01

Last updated by the study team

2011-07-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18-85 years of age
• Blood pressure in the range of 130 to 179/80 to 109 mmHg
• Currently using 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)

You may not qualify if…

• 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
• Diagnosis of hyperthyroidism as determined by lab markers done at screening
• 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

Where it is running

• Forest Investigative Site 16 — Huntsville, Alabama, United States
• Forest Investigative Site 35 — Bell Gardens, California, United States
• Forest Investigative Site — Buena Park, California, United States
• Forest Investigative Site 54 — Chino, California, United States
• Forest Investigative Site 40 — Fremont, California, United States
• Forest Investigative Site — Palm Springs, California, United States
• Forest Investigative Site — Pomona, California, United States
• Forest Investigative Site 55 — Sacramento, California, United States
• Forest Investigative Site 11 — San Diego, California, United States
• Forest Investigative Site — Santa Monica, California, United States
• Forest Investigative Site — Spring Valley, California, United States
• Forest Investigative Site 49 — Tustin, California, United States
• Forest Investigative Site 47 — Walnut Creek, California, United States
• Forest Investigative Site 61 — Golden, Colorado, United States
• Forest Investigative Site — Wheat Ridge, Colorado, United States
• Forest Investigative Site 3 — Daytona Beach, Florida, United States
• Forest Investigative Site 33 — DeLand, Florida, United States
• Forest Investigative Site 36 — Hollywood, Florida, United States
• Forest Investigative Site 62 — Miami, Florida, United States
• Forest Investigative Site 080 — Miami, Florida, United States
• Forest Investigative Site 59 — Miami, Florida, United States
• Forest Investigative Site 32 — Pembroke Pines, Florida, United States
• Forest Investigative Site 081 — Pembroke Pines, Florida, United States
• Forest Investigative Site 2 — Tamarac, Florida, United States
• Forest Investigative Site 15 — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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