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: Recruiting

Sponsored by: Forest Laboratories

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

Overall contact:
Sandra Beaird, PharmD, Phone: 800/678/1605, Ext: 66297, Email: info@forestpharm.com

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:

- 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.

Sandra Beaird, PharmD, Phone: 800/678/1605, Ext: 66297, Email: info@forestpharm.com

Forest Investigative Site, Athens, Alabama 35611, United States; Recruiting

Forest Investigative Site, Huntsville, Alabama 35801, United States; Recruiting

Forest Investigative Site, Tucson, Arizona 85715, United States; Withdrawn

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

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

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

Forest Investigative Site, Los Angeles, California 90211, United States; Withdrawn

Forest Investigative Site, Los Angeles, California 90057, United States; Withdrawn

Forest Investigative Site, Tustin, California 92780, United States; Recruiting

Forest Investigative Site, Encinitas, California 92024, United States; Recruiting

Forest Investigative Site, Temecula, California 92591, United States; Recruiting

Forest Investigative Site, Anaheim, California 92801, United States; Recruiting

Forest Investigative Site, Roseville, California 95661, United States; Withdrawn

Forest Investigative Site, Carmichael, California 95608, United States; Recruiting

Forest Investigative Site, Chino, California 91710, United States; Recruiting

Forest Investigative Site, San Diego, California 92128, United States; Recruiting

Forest Investigative Site, Milford, Connecticut 06460, United States; Recruiting

Forest Investigative Site, Holly Hill, Florida 32117, United States; Recruiting

Forest Investigative Site, DeLand, Florida 32720, United States; Recruiting

Forest Investigative Site, West Palm Beach, Florida 33401, United States; Recruiting

Forest Investigative Site, Hollywood, Florida 33023, United States; Recruiting

Forest Investigative Site, Hialeah, Florida 33012, United States; Recruiting

Forest Investigative Site, Augusta, Georgia 30904, United States; Recruiting

Forest Investigative Site, Atlanta, Georgia 30312, United States; Recruiting

Forest Investigative Site, Atlanta, Georgia 30338, United States; Recruiting

Forest Investigative Site, Honolulu, Hawaii 96814, United States; Active, not recruiting

Forest Investigative Site, Meridian, Idaho 83646, United States; Active, not recruiting

Forest Investigative Site, Chicago, Illinois 60607, United States; Recruiting

Forest Investigative Site, Madisonville, Kentucky 42431, United States; Withdrawn

Forest Investigative Site, Oxon Hill, Maryland 20745, United States; Recruiting

Forest Investigative Site, Brockton, Massachusetts 02301, United States; Suspended

Forest Investigative Site, Paw Paw, Michigan 49079, United States; Withdrawn

Forest Investigative Site, St. Clair Shores, Michigan 48081, United States; Recruiting

Forest Investigative Site, Las Vegas, Nevada 89106, United States; Withdrawn

Forest Investigative Site, East Syracuse, New York 13057, United States; Withdrawn

Forest Investigative Site, New York, New York 10004, United States; Active, not recruiting

Forest Investigative Site, Bronx, New York 10468, United States; Withdrawn

Forest Investigative Site, New York, New York 10001, United States; Recruiting

Forest Investigative Site, Brooklyn, New York 11203, United States; Active, not recruiting

Forest Investigative Site, Charlotte, North Carolina 28207, United States; Withdrawn

Forest Investigative Site, Salisbury, North Carolina 28144, United States; Recruiting

Forest Investigative Site, Charlotte, North Carolina 28262, United States; Recruiting

Forest Investigative Site, Morehead City, North Carolina 28557, United States; Recruiting

Forest Investigative Site, High Point, North Carolina 27262, United States; Recruiting

Forest Investigative Site, Durham, North Carolina 27704, United States; Withdrawn

Forest Investigative Site, Charlotte, North Carolina 28209, United States; Recruiting

Forest Investigative Site, Cincinnati, Ohio 45242, United States; Recruiting

Forest Investigative Site, Centerville, Ohio 45459, United States; Recruiting

Forest Investigative Site, Portland, Oregon 97210, United States; Recruiting

Forest Investigative Site, Eugene, Oregon 97404, United States; Recruiting

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

Forest Investigative Site, Sioux Falls, South Dakota 57104, United States; Recruiting

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

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

Forest Investigative Site, Carrollton, Texas 75006-5810, United States; Recruiting

Forest Investigative Site, Salt Lake City, Utah 84102, United States; Recruiting

Forest Investigative Site, Bountiful, Utah 84010-5174, United States; Recruiting

Forest Investigative Site, Salt Lake City, Utah 84102, United States; Active, not recruiting

Starting date: May 2008
Last updated: January 22, 2009