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”

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.

Study Type: Interventional

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

Study Primary Completion Date: June 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Nebivolol
  • Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration
• Drug: HCTZ
  • Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration.
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Nebivolol
• Active Comparator: 2
  • HCTZ
• Placebo Comparator: 3
  • Placebo

Primary Measures

• Seated diastolic blood pressure (DBP) and plasma glucose level after an oral glucose tolerance test
  • Time Frame: Before treatment and after 12 weeks
    Safety Issue?: No

Secondary Measures

• Homeostasis Model Assessment of Insulin Resistance; seated systolic blood pressure (SBP)
  • Time Frame: Before treatment and during the 12 weeks of treatment
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Forest Laboratories

Overall Clinical Trial Officials and Contacts

David Bharucha, MD, PhD Study Director Forest Laboratories  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00673790

Study ID Number: NEB-MD-04

ClinicalTrials.gov Identifier: NCT00673790

Health Authority: United States: Food and Drug Administration