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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nebivolol with concomitant losartan or lisinopril
* Drug: HCTZ with concomitant losartan or lisinopril
* Drug: Placebo with concomitant losartan or lisinopril


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nebivolol<br>Nebivolol with concomitant losartan or lisinopril | Drug: Nebivolol with concomitant losartan or lisinopril<br>* Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.<br>|
| Active Comparator: Hydrochlorothiazide (HCTZ)<br>HCTZ with concomitant losartan or lisinopril | Drug: HCTZ with concomitant losartan or lisinopril<br>* Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.<br>|
| Placebo Comparator: Placebo<br>Placebo with concomitant losartan or lisinopril | Drug: Placebo with concomitant losartan or lisinopril<br>* Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Seated Diastolic Blood Pressure | Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF). | Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose Level After an Oral Glucose Tolerance Test | 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. | Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebivolol, BYSTOLIC ™, hydrochlorothiazide, lisinopril, Prinivil (TM), Zestril (TM), losartan, Cozaar (TM), Impaired Fasting Glucose, Impaired Glucose Tolerance, hypertension