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

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Nebivolol with concomitant losartan or lisinopril; Drug: HCTZ with concomitant losartan or lisinopril; Drug: Placebo with concomitant losartan or lisinopril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673790

NEB-MD-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 537 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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537 participants in 3 patient groups, including a placebo group

Nebivolol

Active Comparator group

Description:

Nebivolol with concomitant losartan or lisinopril

Treatment:

Drug: Nebivolol with concomitant losartan or lisinopril

Hydrochlorothiazide (HCTZ)

Active Comparator group

Description:

HCTZ with concomitant losartan or lisinopril

Treatment:

Drug: HCTZ with concomitant losartan or lisinopril

Placebo

Placebo Comparator group

Description:

Placebo with concomitant losartan or lisinopril

Treatment:

Drug: Placebo with concomitant losartan or lisinopril