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

Phase 4

Completed

Interventions: Drug: Placebo with concomitant losartan or lisinopril
Drug: Nebivolol with concomitant losartan or lisinopril
Drug: HCTZ with concomitant losartan or lisinopril

Brief Summary: 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.

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 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo with concomitant losartan or lisinopril	Placebo with concomitant losartan or lisinopril
Nebivolol	Nebivolol with concomitant losartan or lisinopril	Nebivolol with concomitant losartan or lisinopril
Hydrochlorothiazide (HCTZ)	HCTZ with concomitant losartan or lisinopril	HCTZ with concomitant losartan or lisinopril

Primary Outcome Measures

Name	Time	Method
Trough Seated Diastolic Blood Pressure	Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)	Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).

Secondary Outcome Measures

Name	Time	Method
Plasma Glucose Level After an Oral Glucose Tolerance Test	Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)	Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.

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Forest Investigative Site 058
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