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

Condition(s) targeted: Hypertension

Intervention: Nebivolol (Drug); HCTZ (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
David Bharucha, MD, PhD, Study Director, Affiliation: Forest Laboratories

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Seated diastolic blood pressure (DBP) and plasma glucose level after an oral glucose tolerance test

Secondary outcome: Homeostasis Model Assessment of Insulin Resistance; seated systolic blood pressure (SBP)

Detailed description: 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 450 patients at approximately 60 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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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:

- History of smoking (use of tobacco products within 6 months of study entry and at any

time during the study.

- Have clinically significant respiratory, liver or cardiovascular disease

- Presence of coronary artery disease requiring treatmetn 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.

Forest Investigative Site, Athens, Alabama 35611, United States

Forest Investigative Site, Huntsville, Alabama 35801, United States

Forest Investigative Site, Tucson, Arizona 85715, United States

Forest Investigative Site, Buena Park, California 90620, United States

Forest Investigative Site, Long Beach, California 90806, United States

Forest Investigative Site, Walnut Creek, California 94598, United States

Forest Investigative Site, Los Angeles, California 90211, United States

Forest Investigative Site, Los Angeles, California 90057, United States

Forest Investigative Site, Tustin, California 92780, United States

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Forest Investigative Site, Carmichael, California 95608, United States

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Forest Investigative Site, Cincinnati, Ohio 45242, United States

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Forest Investigative Site, Portland, Oregon 97220, United States

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Forest Investigative Site, Pawtucket, Rhode Island 02860, United States

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Forest Investigative Site, San Antonio, Texas 78229-4801, United States

Forest Investigative Site, San Antonio, Texas 78229, United States

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Starting date: May 2008
Last updated: May 20, 2008