The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose



Status:Completed
Conditions:High Blood Pressure (Hypertension), Endocrine
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - 80
Updated:10/14/2017
Start Date:May 2008

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Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose

This study is being done to see if the blood pressure and metabolic effects of an approved
drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and
placebo in hypertensive patients.

This study is double blind (neither you nor the physician will know when you are receiving
placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol
or hydrochlorothiazide).

All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan,
an angiotensin receptor blocker. All medications are approved and marketed for the treatment
of hypertension.This study is being conducted in about 500 patients at approximately 80
research centers in the United States.

The study consists of approximately 9 study visits over a period of 5 months. During these
visits, patients will undergo routine health exams and some special laboratory tests such as
an oral glucose tolerance test.

Inclusion Criteria:

- Male or female, ambulatory outpatients 18-80 years old at screening.

- Have a history of hypertension and taking up to 2 medications for high blood pressure.

- Qualifying laboratory results confirming impaired fasting glucose or impaired glucose
tolerance

- Vision and hearing (hearing aid permissible) sufficient for compliance with
questionnaire completion

Exclusion Criteria:

- Have clinically significant respiratory, liver or cardiovascular disease

- Presence of coronary artery disease requiring treatment with a beat blocker, calcium
channel blocker or nitrates

- Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study
entry

- Have a history of hypersensitivity to nebivolol, other beta-blockers,
hydrochlorothiazide, or other sulfonamide-derived drugs.
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