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Status:

COMPLETED

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

Lead Sponsor:

Forest Laboratories

Conditions:

Hypertension

Type 2 Diabetes Mellitus

Eligibility:

All Genders

18-85 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    231 Patients enrolled

    Trial Details

    Trial ID

    NCT00744237

    Start Date

    August 1 2008

    Last Update

    July 29 2011

    Active Locations (65)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 17 (65 locations)

    1

    Forest Investigative Site 15

    Athens, Alabama, United States, 35611

    2

    Forest Investigative Site 16

    Huntsville, Alabama, United States, 35801

    3

    Forest Investigative Site 35

    Bell Gardens, California, United States, 90201

    4

    Forest Investigative Site

    Buena Park, California, United States, 90620